Joseph Tierney has over 12 years of experience in microbiology and food safety roles. He holds a PhD in microbiology and has worked in management roles at several large food companies, including Diageo, Nestle, and Kellogg. Currently he works as the Lead Hygienist and Food Safety SME for Kellogg Europe and Russia, where he leads sanitation and food safety training programs.
Aida Melendez has over 30 years of experience in the pharmaceutical industry as a chemist, manager, and environmental project manager. She has expertise in areas such as manufacturing operations, quality assurance, laboratory management, and regulatory compliance. She is bilingual in English and Spanish and has a proven track record of managing teams and projects. She holds a B.S. in Chemistry and additional certifications in bioscience technology and quality systems.
This document provides an executive summary and career profile for Dr. B. Guruswamy, who has over 17 years of experience in API research, process development, scale up, and life cycle management in the pharmaceutical industry. He is currently a Senior Principal Scientist at Neuland Laboratories in Hyderabad, India, where he leads a team of 20 scientists in multiple projects related to API synthesis and process optimization. The summary highlights his educational background, roles and responsibilities, career achievements, areas of expertise, publications, patents, and research experience.
Dr. A. Muruganantham has over 14 years of experience in seaweed processing and organic fertilizer manufacturing, including roles in quality assurance, research and development, and production. He currently works as a technical expert for a company that produces seaweed-based hydrocolloids and organic plant nutrients. His expertise includes seaweed farming, fertilizer production, laboratory operations, and new product development using seaweeds.
I am in quest of senior level assignments as Functional Lead - Quality Control/ Quality Assurance with an organization of repute in Denmark or nearby Schengen countries.
The document provides a summary of Robert Llantero Loquillano's background and qualifications as a microbiologist and plant pathologist. It includes details of his educational background in applied biology and phytopathology. It also outlines his work experience in quality control and microbiology roles for various companies in Saudi Arabia, the UAE, and the Philippines. It highlights his skills in implementing standards like HACCP, cGMP, ISO, and developing quality manuals.
This document contains the resume of Dr. Mahesh K Dalal. It summarizes his work experience, responsibilities, and qualifications. Some key details include:
- Over 21 years of experience in research and development, quality control, quality assurance, teaching, and consulting.
- Currently works as a consultant in Ahmedabad, India and previously worked at Dorf Ketal Speciality Catalysts Pvt. Ltd. as Deputy General Manager.
- Holds a Ph.D. in Chemistry and has 18 publications in international and national journals, books, and patents. Also presented in 12 conferences.
Position Summary:
Responsible for developing, implementing and managing systems to mitigate the risk of experiencing unacceptable levels of bioburden in products. This includes establishing best practices, process controls and environmental monitoring programs that reduce the potential for microbial product contamination. Also responsible for training manufacturing associates on aseptic technique and monitoring and coaching production associates at their work stations.
Key Responsibilities:
•Microbial sampling, identification & bioburden mapping of production facilities.
•Bioburden challenge studies for existing and new product formulations.
•Bioburden risk assessment and validation for new product development process.
•Aseptic process development and process control.
•Environmental and water monitoring of Rockford and Wisconsin sites.
•Interpret test results and initiate corrective actions as needed.
•Assist with equipment and process cleaning validations.
•Clean room management inclusive of mentoring and supervising 23 clean room associates.
•Microbial test-method development as per USP test method suitability.
•Contamination investigations & implementation of corrective actions.
•Prepare reports and present data with conclusions.
•Maintain microbiology laboratory equipment and supplies.
Also efficiently performed Preservative Efficacy Challenge Tests, Environmental monitoring, LAL Endotoxin testing (Kinetic & Gel Clot methods), Microbial Ingress Integrity Testing (both Dye Penetration & Bacterial Challenge testing), Microbial Identification using Biolog, Mycoplasma testing of products using Luminometer, Bioburden & Water testing.
Murali Krishna N is a Quality Assurance professional with over 4 years of experience in pharmaceutical companies. He has a M.Sc. in Biotechnology and B.Sc. in Biotechnology, Zoology, and Chemistry. He is currently working as an Executive Quality Assurance at Aurobindo Pharma Ltd where he is responsible for change controls, audits, sampling, and ensuring compliance. Previously he worked at Indian Immunologicals Ltd as an Officer in Quality Assurance where he performed in-process checks and monitoring, sampling, and maintaining GMP compliance.
Aida Melendez has over 30 years of experience in the pharmaceutical industry as a chemist, manager, and environmental project manager. She has expertise in areas such as manufacturing operations, quality assurance, laboratory management, and regulatory compliance. She is bilingual in English and Spanish and has a proven track record of managing teams and projects. She holds a B.S. in Chemistry and additional certifications in bioscience technology and quality systems.
This document provides an executive summary and career profile for Dr. B. Guruswamy, who has over 17 years of experience in API research, process development, scale up, and life cycle management in the pharmaceutical industry. He is currently a Senior Principal Scientist at Neuland Laboratories in Hyderabad, India, where he leads a team of 20 scientists in multiple projects related to API synthesis and process optimization. The summary highlights his educational background, roles and responsibilities, career achievements, areas of expertise, publications, patents, and research experience.
Dr. A. Muruganantham has over 14 years of experience in seaweed processing and organic fertilizer manufacturing, including roles in quality assurance, research and development, and production. He currently works as a technical expert for a company that produces seaweed-based hydrocolloids and organic plant nutrients. His expertise includes seaweed farming, fertilizer production, laboratory operations, and new product development using seaweeds.
I am in quest of senior level assignments as Functional Lead - Quality Control/ Quality Assurance with an organization of repute in Denmark or nearby Schengen countries.
The document provides a summary of Robert Llantero Loquillano's background and qualifications as a microbiologist and plant pathologist. It includes details of his educational background in applied biology and phytopathology. It also outlines his work experience in quality control and microbiology roles for various companies in Saudi Arabia, the UAE, and the Philippines. It highlights his skills in implementing standards like HACCP, cGMP, ISO, and developing quality manuals.
This document contains the resume of Dr. Mahesh K Dalal. It summarizes his work experience, responsibilities, and qualifications. Some key details include:
- Over 21 years of experience in research and development, quality control, quality assurance, teaching, and consulting.
- Currently works as a consultant in Ahmedabad, India and previously worked at Dorf Ketal Speciality Catalysts Pvt. Ltd. as Deputy General Manager.
- Holds a Ph.D. in Chemistry and has 18 publications in international and national journals, books, and patents. Also presented in 12 conferences.
Position Summary:
Responsible for developing, implementing and managing systems to mitigate the risk of experiencing unacceptable levels of bioburden in products. This includes establishing best practices, process controls and environmental monitoring programs that reduce the potential for microbial product contamination. Also responsible for training manufacturing associates on aseptic technique and monitoring and coaching production associates at their work stations.
Key Responsibilities:
•Microbial sampling, identification & bioburden mapping of production facilities.
•Bioburden challenge studies for existing and new product formulations.
•Bioburden risk assessment and validation for new product development process.
•Aseptic process development and process control.
•Environmental and water monitoring of Rockford and Wisconsin sites.
•Interpret test results and initiate corrective actions as needed.
•Assist with equipment and process cleaning validations.
•Clean room management inclusive of mentoring and supervising 23 clean room associates.
•Microbial test-method development as per USP test method suitability.
•Contamination investigations & implementation of corrective actions.
•Prepare reports and present data with conclusions.
•Maintain microbiology laboratory equipment and supplies.
Also efficiently performed Preservative Efficacy Challenge Tests, Environmental monitoring, LAL Endotoxin testing (Kinetic & Gel Clot methods), Microbial Ingress Integrity Testing (both Dye Penetration & Bacterial Challenge testing), Microbial Identification using Biolog, Mycoplasma testing of products using Luminometer, Bioburden & Water testing.
Murali Krishna N is a Quality Assurance professional with over 4 years of experience in pharmaceutical companies. He has a M.Sc. in Biotechnology and B.Sc. in Biotechnology, Zoology, and Chemistry. He is currently working as an Executive Quality Assurance at Aurobindo Pharma Ltd where he is responsible for change controls, audits, sampling, and ensuring compliance. Previously he worked at Indian Immunologicals Ltd as an Officer in Quality Assurance where he performed in-process checks and monitoring, sampling, and maintaining GMP compliance.
Ashish Kumar Mishra has over 9 years of experience in quality assurance and operations management. He is currently an Assistant Manager at Cargill India Pvt. Ltd., where he oversees quality assurance operations at three locations. He has expertise in implementing food safety and quality standards like HACCP, ISO 22000, and FSSC 2200. He also has a Green Belt certification in Lean Six Sigma and has received several awards for his work improving processes around recipe accuracy, moisture management, and inventory control.
This document provides a summary of Vimlendu Pandey's experience and qualifications. It outlines his 16 years of experience in analytical microbiology and microbiological research. Currently, he is the Deputy General Manager at Microchem Silliker Private Limited in Delhi, where he oversees overall laboratory operations. Previously, he held several leadership roles at other accredited laboratories, including managing microbiology labs and operations. He also has extensive experience in research and development related to microbiology.
Ariel Natividad has over 20 years of experience working in quality assurance roles for Nestle Philippines. He currently works as a Quality Assurance Supervisor at Nestle's Cabuyao factory, where he ensures good laboratory practices and maintenance of equipment and supplies. Previously he held roles as a Quality Assurance Analyst and Assistant at several Nestle factories, conducting various chemical and microbiological testing on raw materials, products and equipment to ensure compliance with specifications.
The document is a curriculum vitae for Shivani Bhatia that summarizes her professional experience and qualifications. It shows that she has over 10 years of experience in microbiology roles in New Zealand, including as a Senior Microbiologist and Microbiology Supervisor at Synlait Milk and AsureQuality. She also held microbiology technician roles at several other companies. Bhatia has a Postgraduate Diploma in Applied Sciences from Lincoln University and a Bachelor of Science from Punjab University.
Arra Nampally is currently an Assistant Manager at Sanofi India, with over 11 years of experience in quality control for pharmaceutical formulations. She has a Master's degree from Periyar University and a BSc from Osmania University. As Assistant Manager, she leads a team and is responsible for day-to-day operations of the quality control microbiology department to ensure goals are achieved. She has experience with audits, equipment qualification, method development and validation, and ensuring regulatory compliance.
D. Revathi is seeking challenging opportunities in biotechnology to strengthen her passion in the field. She has an M.Tech in Biochemical Engineering and Biotechnology from Osmania University College of Technology and a B.Tech in Biotechnology from JNTU Hyderabad. She has work experience in process optimization for lipase production, genetic toxicology studies, production and quality control of dairy products, and more. Revathi also has strong laboratory skills, publications, presentations, and high GATE scores, demonstrating her expertise in biotechnology.
Aaron Hagel has over 10 years of experience in quality assurance and quality control roles. He possesses skills in quality control, quality assurance, data management, statistical analysis and process improvement. Hagel has a Master of Business Administration and a Master of Human Resource Management from Keller Graduate School of Management. He is a member of the American Society for Quality and has held roles as a quality control technician and lab technician at several companies, including Randstad, Monsanto, PPG Industries, and Hexion Specialty Chemicals.
This summary provides an overview of Karen Cash's 20+ years of experience in quality roles in the biotech industry:
- She has extensive experience in quality assurance, quality control testing, process improvements, and complaint investigations for biotech and medical device companies.
- Her most recent role was as a Quality Assurance Scientist investigating complaints at Beckman Coulter, where she analyzed data to determine causes and ensure compliance.
- She is looking to transfer her quality skills to the medical device industry in the Minneapolis area, having recently relocated from Wisconsin.
This document is a resume for Ghulam Sajjad. It summarizes his professional experience and qualifications. Sajjad has over 12 years of experience in microbiology and quality assurance roles. He is currently the Head of Food Microbiology Department at Intertek Pakistan, where he oversees microbiological testing and ensures compliance with quality standards. Previously, he held senior quality assurance roles at Barrett Hodgson Pakistan and ATCO Laboratories, where he performed microbiological testing, audits, and method validations. Sajjad has a Master's degree and Bachelor's degree in Microbiology from the University of Karachi. He is proficient in microbiological techniques, quality systems, and computer skills.
Karen Campbell is seeking a position that utilizes her experience in quality assurance and process improvement. She has over 30 years of experience in medical laboratories and 13 years as Quality Assurance Manager at ThermoFisher Scientific, where she developed quality processes, standard operating procedures, metric boards, and led corrective actions. She is trained in Lean Enterprise techniques and served as an internal ISO auditor.
This document provides a summary of Satyanarayana's qualifications and experience. He has over 10 years of experience in quality assurance and has worked in various roles ensuring compliance with quality standards. He holds an MSc in Biotechnology and has received training in quality management systems. His previous roles involved managing quality systems, conducting audits, ensuring regulatory compliance, and overseeing laboratory operations and testing.
Atul Borse has over 4 years of experience in quality control and quality assurance. He has a Master's degree in Analytical Chemistry and is proficient in using instruments like HPLC, GC, FTIR, and UV spectrophotometers. Currently he works as an executive in quality assurance at Johnson & Johnson Ltd. where he handles market complaints and ensures compliance with quality standards. Previously he has worked for other pharmaceutical companies like Wockhardt and Ajanta Pharmaceuticals in roles with increasing responsibility. He is skilled in documentation management, audits, and ensuring compliance with GMP, ISO, and regulatory guidelines.
Greencore, a $2.2B food manufacturer, implemented CDC Factory to improve factory efficiencies and support a cost reduction initiative. CDC Factory provided real-time operations data to empower floor workers. This identified issues like product re-work, long changeover times, and downtime causes. Solutions like optimizing line speeds, streamlining changeovers, and adding mixing equipment reduced direct costs by 5% and improved productivity. The system also changed culture by empowering workers and transitioning managers to a ratifying role of shop floor improvements.
GLP (Good Laboratory Practice) is a quality system concerned with the organization and conditions under which non-clinical health and environmental safety studies are conducted. It was instituted in the US after fraudulent data was submitted by toxicology labs to the FDA. The OECD then established principles of GLP to harmonize standards internationally. The key principles cover organization and personnel, quality assurance, facilities, equipment, test systems, study conduct, reporting and record keeping. Compliance ensures the validity and integrity of study data submitted to regulatory authorities like the FDA. India has a National GLP Compliance Monitoring Authority that inspects and certifies laboratories according to OECD GLP principles.
Good Laboratory Practice (GLP) regulations were created by the FDA in the 1970s after discovering fraudulent activities and poor lab practices that undermined the quality and integrity of data submitted to the FDA. GLP aims to ensure that studies are conducted properly according to standardized operating procedures and that accurate records are kept. This allows data from non-clinical studies to be reliably submitted to regulatory authorities. Key aspects of GLP include requirements for facilities, test systems, operating procedures, personnel qualifications, quality assurance programs, and record keeping. Following GLP helps assure reproducibility and quality of results.
This document provides an overview of Good Laboratory Practice (GLP) standards. GLP standards are concerned with ensuring quality in non-clinical health and safety studies. They aim to promote quality data and sound management of laboratory studies. GLP standards apply to non-clinical studies intended to evaluate safety for submission to regulatory authorities. Key aspects of GLP covered include resources, facilities, equipment, personnel responsibilities and training, characterization of test items, study protocols, record keeping, and quality assurance.
GLP regulations were established in the 1970s in response to issues in pharmaceutical R&D. GLP provides a quality system for non-clinical studies by requiring organization, facilities, personnel, test characterization, study plans, and record-keeping. Key aspects of GLP include defining organizational structure and staff responsibilities, ensuring adequate facilities and equipment, documenting test materials and systems, having written protocols and procedures, recording raw data, archiving records, and independent quality assurance oversight of studies. GLP applies primarily to safety studies for products regulated by drug authorities.
The document provides a summary of Aravind Kumar Soni's background and experience as a Production and Quality Management Professional in the biotechnology sector. It details his current role spearheading quality control operations at Quad Life Sciences Private Ltd in Punjab, along with previous relevant experience. Key skills and responsibilities include quality management systems, audits, batch processing, documentation, and ensuring compliance with international standards.
An IRCA certified Lead Auditor of the Food Safety Management System, heading the QA functions & Hygiene with overall 19 years experience in Aviation/ in-flight Catering. Expertise in Six Sigma, Food Safety & Hygiene Audits, Medina QSAI Food Safety & Quality Validation Audits with exposure of International Airlines inflight Catering experiences.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities,
Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct
of a Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing
Facilities
Kalyani Kadam has over 20 years of experience in quality assurance and microbiology. She currently works as an Application Specialist at Span Biotronics, where she is involved in product development, validation, and customer support. Previously, she held roles such as Project Manager, Assistant Product Manager, and Microbiologist at various companies. Kadam has a Bachelor's degree in Microbiology and qualifications in nutrition, sterility approval, and laboratory quality systems. She is married and resides in Mumbai, India.
Daragh Comer has experience working in medical device and pharmaceutical companies, including over a year as a graduate intern at Medtronic in quality management and microbiology. He has a BSc in Microbiology and Biochemistry from National University of Ireland, Galway, and certifications in ethylene oxide sterilization. His experience includes creating quality management systems, auditing documents, environmental monitoring, testing, data analysis, and training. In his spare time, he enjoys electronic music, sports, traveling and meeting new people from different cultures.
Ashish Kumar Mishra has over 9 years of experience in quality assurance and operations management. He is currently an Assistant Manager at Cargill India Pvt. Ltd., where he oversees quality assurance operations at three locations. He has expertise in implementing food safety and quality standards like HACCP, ISO 22000, and FSSC 2200. He also has a Green Belt certification in Lean Six Sigma and has received several awards for his work improving processes around recipe accuracy, moisture management, and inventory control.
This document provides a summary of Vimlendu Pandey's experience and qualifications. It outlines his 16 years of experience in analytical microbiology and microbiological research. Currently, he is the Deputy General Manager at Microchem Silliker Private Limited in Delhi, where he oversees overall laboratory operations. Previously, he held several leadership roles at other accredited laboratories, including managing microbiology labs and operations. He also has extensive experience in research and development related to microbiology.
Ariel Natividad has over 20 years of experience working in quality assurance roles for Nestle Philippines. He currently works as a Quality Assurance Supervisor at Nestle's Cabuyao factory, where he ensures good laboratory practices and maintenance of equipment and supplies. Previously he held roles as a Quality Assurance Analyst and Assistant at several Nestle factories, conducting various chemical and microbiological testing on raw materials, products and equipment to ensure compliance with specifications.
The document is a curriculum vitae for Shivani Bhatia that summarizes her professional experience and qualifications. It shows that she has over 10 years of experience in microbiology roles in New Zealand, including as a Senior Microbiologist and Microbiology Supervisor at Synlait Milk and AsureQuality. She also held microbiology technician roles at several other companies. Bhatia has a Postgraduate Diploma in Applied Sciences from Lincoln University and a Bachelor of Science from Punjab University.
Arra Nampally is currently an Assistant Manager at Sanofi India, with over 11 years of experience in quality control for pharmaceutical formulations. She has a Master's degree from Periyar University and a BSc from Osmania University. As Assistant Manager, she leads a team and is responsible for day-to-day operations of the quality control microbiology department to ensure goals are achieved. She has experience with audits, equipment qualification, method development and validation, and ensuring regulatory compliance.
D. Revathi is seeking challenging opportunities in biotechnology to strengthen her passion in the field. She has an M.Tech in Biochemical Engineering and Biotechnology from Osmania University College of Technology and a B.Tech in Biotechnology from JNTU Hyderabad. She has work experience in process optimization for lipase production, genetic toxicology studies, production and quality control of dairy products, and more. Revathi also has strong laboratory skills, publications, presentations, and high GATE scores, demonstrating her expertise in biotechnology.
Aaron Hagel has over 10 years of experience in quality assurance and quality control roles. He possesses skills in quality control, quality assurance, data management, statistical analysis and process improvement. Hagel has a Master of Business Administration and a Master of Human Resource Management from Keller Graduate School of Management. He is a member of the American Society for Quality and has held roles as a quality control technician and lab technician at several companies, including Randstad, Monsanto, PPG Industries, and Hexion Specialty Chemicals.
This summary provides an overview of Karen Cash's 20+ years of experience in quality roles in the biotech industry:
- She has extensive experience in quality assurance, quality control testing, process improvements, and complaint investigations for biotech and medical device companies.
- Her most recent role was as a Quality Assurance Scientist investigating complaints at Beckman Coulter, where she analyzed data to determine causes and ensure compliance.
- She is looking to transfer her quality skills to the medical device industry in the Minneapolis area, having recently relocated from Wisconsin.
This document is a resume for Ghulam Sajjad. It summarizes his professional experience and qualifications. Sajjad has over 12 years of experience in microbiology and quality assurance roles. He is currently the Head of Food Microbiology Department at Intertek Pakistan, where he oversees microbiological testing and ensures compliance with quality standards. Previously, he held senior quality assurance roles at Barrett Hodgson Pakistan and ATCO Laboratories, where he performed microbiological testing, audits, and method validations. Sajjad has a Master's degree and Bachelor's degree in Microbiology from the University of Karachi. He is proficient in microbiological techniques, quality systems, and computer skills.
Karen Campbell is seeking a position that utilizes her experience in quality assurance and process improvement. She has over 30 years of experience in medical laboratories and 13 years as Quality Assurance Manager at ThermoFisher Scientific, where she developed quality processes, standard operating procedures, metric boards, and led corrective actions. She is trained in Lean Enterprise techniques and served as an internal ISO auditor.
This document provides a summary of Satyanarayana's qualifications and experience. He has over 10 years of experience in quality assurance and has worked in various roles ensuring compliance with quality standards. He holds an MSc in Biotechnology and has received training in quality management systems. His previous roles involved managing quality systems, conducting audits, ensuring regulatory compliance, and overseeing laboratory operations and testing.
Atul Borse has over 4 years of experience in quality control and quality assurance. He has a Master's degree in Analytical Chemistry and is proficient in using instruments like HPLC, GC, FTIR, and UV spectrophotometers. Currently he works as an executive in quality assurance at Johnson & Johnson Ltd. where he handles market complaints and ensures compliance with quality standards. Previously he has worked for other pharmaceutical companies like Wockhardt and Ajanta Pharmaceuticals in roles with increasing responsibility. He is skilled in documentation management, audits, and ensuring compliance with GMP, ISO, and regulatory guidelines.
Greencore, a $2.2B food manufacturer, implemented CDC Factory to improve factory efficiencies and support a cost reduction initiative. CDC Factory provided real-time operations data to empower floor workers. This identified issues like product re-work, long changeover times, and downtime causes. Solutions like optimizing line speeds, streamlining changeovers, and adding mixing equipment reduced direct costs by 5% and improved productivity. The system also changed culture by empowering workers and transitioning managers to a ratifying role of shop floor improvements.
GLP (Good Laboratory Practice) is a quality system concerned with the organization and conditions under which non-clinical health and environmental safety studies are conducted. It was instituted in the US after fraudulent data was submitted by toxicology labs to the FDA. The OECD then established principles of GLP to harmonize standards internationally. The key principles cover organization and personnel, quality assurance, facilities, equipment, test systems, study conduct, reporting and record keeping. Compliance ensures the validity and integrity of study data submitted to regulatory authorities like the FDA. India has a National GLP Compliance Monitoring Authority that inspects and certifies laboratories according to OECD GLP principles.
Good Laboratory Practice (GLP) regulations were created by the FDA in the 1970s after discovering fraudulent activities and poor lab practices that undermined the quality and integrity of data submitted to the FDA. GLP aims to ensure that studies are conducted properly according to standardized operating procedures and that accurate records are kept. This allows data from non-clinical studies to be reliably submitted to regulatory authorities. Key aspects of GLP include requirements for facilities, test systems, operating procedures, personnel qualifications, quality assurance programs, and record keeping. Following GLP helps assure reproducibility and quality of results.
This document provides an overview of Good Laboratory Practice (GLP) standards. GLP standards are concerned with ensuring quality in non-clinical health and safety studies. They aim to promote quality data and sound management of laboratory studies. GLP standards apply to non-clinical studies intended to evaluate safety for submission to regulatory authorities. Key aspects of GLP covered include resources, facilities, equipment, personnel responsibilities and training, characterization of test items, study protocols, record keeping, and quality assurance.
GLP regulations were established in the 1970s in response to issues in pharmaceutical R&D. GLP provides a quality system for non-clinical studies by requiring organization, facilities, personnel, test characterization, study plans, and record-keeping. Key aspects of GLP include defining organizational structure and staff responsibilities, ensuring adequate facilities and equipment, documenting test materials and systems, having written protocols and procedures, recording raw data, archiving records, and independent quality assurance oversight of studies. GLP applies primarily to safety studies for products regulated by drug authorities.
The document provides a summary of Aravind Kumar Soni's background and experience as a Production and Quality Management Professional in the biotechnology sector. It details his current role spearheading quality control operations at Quad Life Sciences Private Ltd in Punjab, along with previous relevant experience. Key skills and responsibilities include quality management systems, audits, batch processing, documentation, and ensuring compliance with international standards.
An IRCA certified Lead Auditor of the Food Safety Management System, heading the QA functions & Hygiene with overall 19 years experience in Aviation/ in-flight Catering. Expertise in Six Sigma, Food Safety & Hygiene Audits, Medina QSAI Food Safety & Quality Validation Audits with exposure of International Airlines inflight Catering experiences.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities,
Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct
of a Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing
Facilities
Kalyani Kadam has over 20 years of experience in quality assurance and microbiology. She currently works as an Application Specialist at Span Biotronics, where she is involved in product development, validation, and customer support. Previously, she held roles such as Project Manager, Assistant Product Manager, and Microbiologist at various companies. Kadam has a Bachelor's degree in Microbiology and qualifications in nutrition, sterility approval, and laboratory quality systems. She is married and resides in Mumbai, India.
Daragh Comer has experience working in medical device and pharmaceutical companies, including over a year as a graduate intern at Medtronic in quality management and microbiology. He has a BSc in Microbiology and Biochemistry from National University of Ireland, Galway, and certifications in ethylene oxide sterilization. His experience includes creating quality management systems, auditing documents, environmental monitoring, testing, data analysis, and training. In his spare time, he enjoys electronic music, sports, traveling and meeting new people from different cultures.
I am seeking to obtain a position with a progressive, large international company or organization offering responsibility, advancement& individual growth.
•To find a career opportunity that would utilized abroad range of my experience
•To work in a dynamic & corporate environment, which will enable me to apply my expertise and problem solving skills, gained through advanced tertiary qualifications, work experience & international accreditations, to the best benefit of organization thereby achieving symbiotic growth
Nandakumar Narayanan Kutty is a highly qualified microbiologist currently pursuing an MBA. He has experience in quality control and marketing for healthcare companies in Abu Dhabi and Bengaluru. He holds a Six Sigma Green Belt certification and has implemented lean six sigma initiatives to improve productivity. Kutty is seeking a position in healthcare quality or marketing where he can apply his expertise in auditing, quality control, and driving business growth.
Praveen Kumar Galla has over 10 years of experience in the biopharmaceutical industry, having worked at companies like Biocon, Wockhardt, and Syngene. He currently works as an R&D Manager at GeneSys Biologics, leading a team that is setting up a laboratory for microbial expression. Praveen has expertise in upstream and downstream processing, process development, equipment operation, and cGMP compliance. He aims to take on new challenges and help the Indian biopharma industry through roles in middle management.
I am seeking to obtain a position with a progressive, large international company or organization offering responsibility, advancement& individual growth.
•To find a career opportunity that would utilized abroad range of my experience
•To work in a dynamic & corporate environment, which will enable me to apply my expertise and problem solving skills, gained through advanced tertiary qualifications, work experience & international accreditations, to the best benefit of organization thereby achieving symbiotic growth.
- Sunil Kumar Singh has over 15 years of experience in analytical chemistry and quality control roles at various agrochemical and pharmaceutical companies.
- He is currently an Assistant Manager at Nagarjuna Agrichem Limited, where he manages analytical testing and develops new methods to analyze raw materials and products.
- Previously he has held roles such as Senior Research Scientist and Study Director, where he ensured compliance with GLP standards and oversaw the conduct of studies.
- He has a B.Sc. and M.Sc. in Chemistry and is proficient in the operation of analytical instruments like GC, HPLC, GC-MS and their use in method development and validation.
Brian Pickering has over 15 years of experience in microbiology quality control and assurance roles within the biologics manufacturing industry. His experience includes establishing environmental and raw materials monitoring programs, training personnel, managing microbiology laboratories, ensuring compliance with regulations, and representing companies in regulatory audits and responses. He currently serves as the QC Raw Materials Microbiology Manager at Sanofi Genzyme in Northborough, MA where he manages various microbiology and contamination control programs.
Ajay Kumar Sharma's resume summarizes his academic qualifications and extensive experience in quality assurance and laboratory management. He holds an M.Phil. and M.Sc. in Microbiology and has worked in roles such as Quality Manager, Laboratory Coordinator, and Government Analyst at two organizations for over 14 years. His responsibilities have included implementing quality management systems, conducting microbiological and chemical analyses, supervising laboratory operations, and ensuring compliance with various accreditation standards.
Good Laboratory Practices (GLP) are quality standards for designing, conducting, recording, and reporting non-clinical research studies that generate data as safety and efficacy information for health or environmental regulations. GLP was developed to increase quality and validity of non-clinical safety studies by defining roles, responsibilities, standard operating procedures, and documentation requirements. Key elements of GLP include management and quality assurance systems, personnel qualifications, facility organization and maintenance, test and control article characterization, standard operating procedures, documentation, and reporting.
Guillermo Faggioli has over 20 years of experience in quality assurance, food safety, and processing across various industries including pet food, fruit juice, bottled water, and packaging. He currently serves as the Regional Quality and Food Safety Manager for Mars Petcare Pet Specialty, where he is responsible for quality and food safety processes across four factories. Previously he held quality and food safety roles at The Nutro Company and Welch's Foods.
This document is a resume for K. Naveen Kumar. It summarizes his career objective, qualifications, education, employment experience and projects. For his career objective, Naveen wants to work for a solution-oriented team where he can utilize his passion for social responsibility and research. His qualifications include experience in food and pharmaceutical manufacturing, testing, quality control and product development. Naveen has a B.Tech in Biotechnology and currently works as an effluent treatment plant maintenance engineer. He also had an internship in quality assurance for a mango pulping industry.
The document provides a summary of qualifications for Md. Altaf Hossain including over 15 years of experience in pharmaceutical quality control and compliance roles. He is currently the Head of QC & Compliance at ACI Limited with previous experience as Deputy Manager of Quality Control at Beximco Pharmaceuticals Limited and roles at Novartis Bangladesh Limited. He has extensive expertise in analytical testing and regulatory compliance, and has led teams through domestic and international audits.
The document provides details about an internship completed by Aafreen Salim at the Food Analysis Laboratory of Vardan Envirolab from February 20th to May 20th, 2023. It includes an acknowledgment, introduction to the laboratory, details of the management team and various departments. Standard operating procedures for proximate analysis methods like moisture, ash, protein, fat, carbohydrate, energy and dietary fiber determination are also outlined.
This document provides a summary of Manoj Kumar Parida's professional experience and qualifications. It lists his current role as Senior Manager of Quality Control (Microbiology) at Emcure Pharmaceuticals Ltd. It then outlines his 16 years of experience in microbiology roles at various pharmaceutical companies. The document details his responsibilities in directing microbiology laboratories and ensuring compliance with regulatory standards.
Good laboratory practices
introduction
reasons behind the creation of glp
Objectives of GLP
The OECD
GLP principles
Test facility organizational and personnel
Quality assurance programme
Facilities
Apparatus, materials and reagents
Test systems
Test and reference items
SOPS- Standard Operating Procedures
Performance of the study
Reporting of the study details
Storage and retention of records and materials
What GLP must contain?
Do this for GLP
Benefits of GLP
Conclusion
Amir Hameed is seeking a challenging position in quality assurance where he can continue developing his skills. He has over 10 years of experience in quality control roles at dairy and ice cream plants. His responsibilities included comprehensive quality testing, ensuring standards compliance, staff training, and continuous quality improvement initiatives. He has certifications in food technology and safety training, and holds a DAE in Food Technology.
Matthew Eric Hulsey is seeking a challenging career opportunity utilizing his manufacturing experience, chemical engineering expertise, and leadership skills. He has over 3 years of experience in manufacturing and operations management roles at Pepsi Beverages Company, where he supervised production lines and led Lean Six Sigma projects. Previously, he completed an internship at Tyco Fire Protection Products where he evaluated fire suppression chemicals and testing procedures. Hulsey holds a Bachelor of Science in Chemical Engineering from the University of Florida and is proficient in various production, sanitation, and computer software.
Wendie Bernard is a highly organized Quality Assurance Professional with experience in the biotechnology industry. She has hands-on experience executing tests and analyses, training others, and leading cross-functional teams to solve problems. She is Green Belt certified in Lean Six Sigma and has various additional certifications in quality auditing and cGMP practices.
Charlie Coco Resume Director of Quality Charlie Coco
Charles Coco Jr. has over 15 years of experience in quality management and analytical chemistry. He has an MS in Chemistry and is a Six Sigma Greenbelt. He is currently working as a Quality Manager for General Nutrition Center, where he establishes KPIs and ensures regulatory compliance. Previously he held various quality leadership roles at biologics and pharmaceutical companies, where he developed analytical methods, managed quality laboratories, and drove continuous quality improvement initiatives.
1. Curriculum Vitae.
Name: Joseph Tierney.
Address: 100 The Synge
Gresham House
Cathal Brugha Street
Dublin 1
E.mail: tierneyjoester@googlemail.com Tel No: 086 8203976
Background.
PhD graduate in microbiology with 12 years post education experience of working in a highly regulated
manufacturing environment at Diageo (Dublin), Abbott (Longford, Ireland), Nestle (Sydney), Kellogg Asia
Pacific and most recently Kellogg Europe based out of Dublin. On completion of my studies in 2003 I began
work at Diageo Baileys Global Supply (DBGS), Dublin as Chief microbiologist for the R+D Brand Technical
Centre where I set-up and ran the microbiology research and development laboratory. I then moved to a start-up
company “Abbott Ireland Diagnostics Division” to work as a technical specialist, and trainer. I moved to
Sydney in September 2007 and I worked as a laboratory manager for East Melbourne Laboratories (EML) for
three and a half years. EML was a fast paced NATA, TGA, ISO and AQIS accredited Microbiology testing
facility for pharmaceutical, food, water and environmental samples. I was an approved NATA signatory for
food, pharmaceutical, water and environmental testing. I managed the day to day running of the laboratory and
dealt with the personnel issues of up to 32 lab assistants, technicians, microbiologists and team leaders. In the
absence of the General Manager I was the acting GM for the site. In June 2010 I joined Nestle, Blacktown,
Australia as site Laboratory manager/Compliance coordinator. Since this time I have actively lead and
participated in site improvement works e.g the launch of Total Performance Management (TPM) and Nestle
Performance Excellence (NCE) for Blacktown and Lean processes (Project Cheetah) for the laboratory. My
team of six people included: two senior chemists, laboratory services officer, two analysts and a quality
development officer. I subsequently moved to Botany, Australia to join Kellogg as lead Sanitarian for Asia
Pacific. My role involved the management of the Sanitation and pest control programmes for: Australia, Japan,
Korea, Thailand, India, Malaysia, China and South Africa. Further expansions of the role lead me to take on
responsibilities in the area of: laboratory auditing, co-manufacturer support, Golden Six roll-outs (food safety
in-house audits) plus Health and Safety duties. This also included an expansion of my role to include QPM
(Quality Performance Manager) responsibilities for Australia and South Africa. The Sanitarian role involved
significant levels of travel and working closely with the factory cross-body teams both locally and Globally in:
engineering, sanitation, safety, operations and procurement to improve the sanitation and pest status status
rating for the region. I was then selected for a role in Kellogg Europe and Russia as Lead Hygienist and Food
Safety SME. The current role is similar to my previous responsibilities for Kellogg Asia Pacific. In July 2015 I
was awarded the Kellogg’s cultural award by demonstrating core values by the successful planning and
execution of a 4 day Sanitation Essentials workshop for Europe, Russia and Turkey based in Bremen Germany.
The award was calculated based on the number of votes cast by my peers within all departments of the Kellogg
European business.
2. Qualifications.
Ph.D. (Microbiology).
College: Dublin Institute of Technology, Cathal Brugha Street, Dublin.
(November 1999-June 2003).
Title: Microbial control in kitchens and laboratory biofilms.
Research objectives:
• Perpetuate microbial biofilms under laboratory conditions.
• Assess various disinfectant protocols.
• Investigate the use of different viability stains.
• Study the effectiveness of disinfectants during microbial biofilm growth and following release.
Laboratory proficiency:
• Disinfectant testing methodologies
• Epifluorescent Microscopy
• BioLogTM
Identification System (culture identification)
• SPSSTM
Software
B.Sc. in Environmental Science and Technology.
College: Sligo Institute of Technology. (1996 – 1999).
Grade: 2.1.
Final year subjects: Environmental microbiology, physical/chemical analysis, resource management,
environmental legislation, air/waste management.
Work Experience.
June 2014- present: Kellogg, Airside Industrial Estate, Sydney (Sanitation and Food
Safety SME Kellogg Europe and Russia)
Achievements:
● Established the Sanitation and IPM dashboard for Kellogg Europe (KEU)
● Management of external cleaning equipment and chemical suppliers for the region
● Organized and lead the 1st
and 2nd
Global Kellogg Sanitation Essentials Workshop,
(June 2014 and June 2015)
● Rolled out hygienic design workbook (HDW) for KEU
● Supported key projects within the area such as: project Napoleon (Co-manufacturer on-
boarding) and project 007 (plant decommissioning).
● Coordinator and lead on food safety, sanitation and pest control training for the region.
● Developed modular training material for sanitation operator training with my global
counterparts in the US and IFPTI.
● Assisted the sites with all technical issues related to external (ISO, BRC) certification
as well as Kellogg internal audit requirements
● Advisor to the sites related to external changes in regulation e.g. product biocidal
directive or internal e.g (Kellogg policy requirements)
● Developed and trained all quality and food safety members on KWS (Kellogg Work
System) - Lean system tools. Process flows related to sanitation, pest control, chemical
management, environmental monitoring. Other pre-requisite program process flows are
in development.
3. October 2011- May 2014: Kellogg, Botany, Sydney (Lead Sanitarian Kellogg Asia
Pacific)
Achievements:
● Established the Sanitation and IPM dashboard for Kellogg Asia Pacific (KAPAC)
● Management of external cleaning equipment and chemical suppliers for the region
● Organized and lead the 1st
Global Sanitation Essentials Roadshow, Pattaya, Thailand
Feb 17-20 2014
● Rolled out Golden Six training for KAPAC.
● Rolled out Food Safety Master list training for KAPAC
● Rolled out hygienic design workbook (HDW) for KAPAC
● Supported key projects within the area such as: Glico remediation Thailand, Project
Valarchi, India, Project Woza-South Africa, Project Firefox and in planning Project
Trifecta.
● Coordinator and lead on food safety, sanitation and pest control training for the region.
● Set-up and run the laboratory audit programme for KAPAC
June 2010- October 2011: Nestle, Blacktown, Sydney (Compliance Coordinator-
Laboratory manager)
Achievements:
● Implemented new cleaning standards (PPM’s) for the site in coordination with an
onsite operator for lines 1, 2 and 3.
● Factory lead for the roll-out of Clean inspect and lubricate (CIL) standards for the
Blacktown site as part of total performance management (TPM) implementation.
● Management of external contractor’s e.g Ecolab to ensure that appropriate chemicals
are used and the production team are briefed and trained on any new procedure.
● Conduct pest monitoring surveillance onsite.
●Review and update technical documents e.g laboratory monographs plus QMS and
cleaning documents.
● Responsible for the running of a TGA registered laboratory (manager of six full time
employees and one casual team member).
●Introduced Lean principles (project Cheetah) to the Blacktown laboratory. The result of
which achieved a:
-Reduction in lead time for Quick Eze from 10 days to 5 days. A cost saving of 50,000
per annum.
-Reduction in lead time for Calcium Carbonate (active) from 14 days to 7 days. A cost
saving of 30,000 per annum.
-As part of project Cheetah introduced and validated the use of an auto-titrattor to replace
manual wet chemistry titrations. In the process reducing full time equivalent (FTE) hours
by 20% per week.
-Introduced 5S and Kanban to the raw material sampling booth in the warehouse
(reduced sampling time by 20%).
●Site representative for Autonomous maintenance (AM) plus the Education and training
(E+T) link for the factory.
● Compliance Coordinator for the site with responsibilities for communication with
contract manufacturer’s e.g iNova, Blackmores, Bayer and Aspen.
● Insurance of compliance of the site to our TGA licence, ISO 22000, PAS 220, Nestle
QMS and Nestle FSMS.
● Certified Food Safety Lead Auditor (SAI) and Internal lead auditor (Nestle).
●Site contact for the High Boil (therapeutic lozenges) and Compressed (Antacid tablets)
lines.
4. Jan 2007- June 2010: EML, Rydalmere, Sydney (Consultancy microbiological facility)
Laboratory Manager
● Laboratory manager of (29 analyst and 3 team leaders).
● Training coordinator including the conductance of external NATA approved
proficiencies e.g IFM, PTA and manager of rosta’s and work allocation.
● Responsible for the set-up and management of a TGA accredited satellite microbiology
testing facility (Sphere Healthcare).
● Main point of laboratory contact for all TGA, NATA, AQIS, ISO and client audits.
●Clients included: Sanitarium, Coca Cola, ResMed, Green’s, Primo Moratis, Nestle,
Laurent Bakeries, Unilever, Steggles and Bartter to name but some.
● Technical authority for customer’s questions.
● NATA signatory for pharmaceutical, food, water, environmental and bioburden testing.
● Head of the steering committee for the introduction of a media production facility and
sterilization capacity at the Rydalmere site (cost saving 60,000$ p/a).
● Responsible for the maintenance and improvement of productivity within the
laboratory and a key participant in the introduction of 5S principles within the laboratory
(cost saving 40,000$ p/a).
● Head of the Health and Safety Committee of EML, Sydney Branch.
2007: Cetec, (Consultancy Health and Safety Company), University of New South
Wales, Kensington, Sydney
Consultant Health and Safety Officer (Temporary position on arriving in Australia)
● Monitoring and assessing the deconstruction of the Wallace Worth building, Chemistry
Department of the University of New South Wales.
● Particulate and asbestos air monitoring, assessing and classifying chemical, biological
and radiological hazards.
● Management and the implementation of safe and effective work practices.
May 2005-August 15 2006: Abbott Ireland Diagnostic Division, Lisnamuck, Co. Longford (Start-up)
Technical Specialist in the Thyroid Team
● Highly involved in the transfer of my product “AxSYM Free T3” from our parent
company in Lake County Chicago to Longford to meet the requirements of the
transfer sub-plan and Equivalency study protocol.
● Involved in air, product and surface microbial sampling.
● Provide production expertise in the manufacture of Calibrators and Controls and
Bulk materials.
● Provide technical support and undertake investigative work to problem solve issues
that arise and offer solutions.
● Official laboratory trainer in the small solutions laboratory with the responsibility for
the training of new staff
● Proficient in: LIMS, MES, BPC’s, EPAs and DMS
● AxSYM (Abbott platform) trained
January 2004-May 2005: Diageo, (Baileys Global Supply) Nangor Road, Dublin
Chief microbiologist and project manager
• Set-up and commissioned the R+D microbiology laboratory.
• Set-up and compiled all microbiology SOP’s and assisted in the development of a
quality manual.
• Analysed final product and trial ingredients for spoilage and non-spoilage
microorganisms.
• Sterilization validation of product using biological markers and thermocouples.
• Developed microbiological specifications for new products.
• Audited Baileys cream suppliers in Ireland.
5. • Audited Baileys co-packer sites in Germany (Munich, Dusseldorf).
Sept-December 2003: Diageo, (Baileys Global Supply) Nangor Road, Dublin
Quality Control Technician
Line QC supervisor responsible for 20 line staff
Involved product checks on all stages of the production process to ensure ISO and
internal specification compliance.
Nov 1999-June 2003: Dublin Institute of Technology, Cathal Brugha Street,
Dublin 1.
Food safety and microbiology demonstrator
• Guest Lecturer to Pharmaceutical Science students on
biofilmology/microbiology.
• Laboratory Demonstrator to Science undergraduates
• Supervisor of undergraduate and postgraduate projects
Feb-Nov 2002: Burgess/Galvin, Dublin 11, Ireland.
(Disinfectant manufacturer).
Contract microbiologist
Swabbing of surfaces for food pathogens and disinfectant efficacy testing
• Testing of disinfectant products under in-use conditions.
• Compilation and in-house presentation of the results to the managerial staff.
Purpose of which was to ensure compliance of the products with EU requirements
Feb 2000-Sep 2002: Medentech and Co. Ltd, Wexford, Ireland.
(Disinfectant manufacturer).
Contract microbiologist
As above
June-Oct 1998: Eli Lilly S.A, Cork, Ireland.
(Pharmaceutical company).
Environmental analyst
• Air monitoring using isokinetic sampling, waste stream testing for pH, BOD,
COD, NH3 and O2, noise monitoring via Scirus noise meters.
• Development of a waste management strategy.
• Self validation tests via AquachecksTM
• Documentation and compilation of results to ensure compliance to IPC licence.
Interests.
• Professional member of the Australian Society of Microbiology (ASM).
• Professional member of the Australian Institute of Food Technology (AIFST).
Skills.
• Computers: Proficiency with Microsoft Word, Excel, PowerPoint, E.mail, Internet, and LIMS.
• Good interpersonal and communication ability. Proven team leader - problem solver and analytical
thinker. Efficient at multi-tasking and an effective team builder and delegator.
Referees.
Referees available on request.
Publications: