Manoj Kumar Verma has over 13 years of experience in quality assurance roles in the biotech and pharmaceutical industries. He has experience leading quality assurance teams and qualifying facilities and products for regulatory inspections. Currently, he works for Hyde E & C India Pvt. Ltd. as an Assistant Manager of Validation, where he plans and executes commissioning and qualification projects in pharmaceutical plants in India and overseas. He has a MBA in Total Quality Management and an M.Sc. in Microbiology.
NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. This body functions independently under Department of Science and Technology of the Indian Government. NABL is registered via the societies act
This document discusses NABL accreditation, which is a voluntary certification provided by the National Accreditation Board for Testing and Calibration Laboratories (NABL) in India. NABL assesses laboratories for technical competence and provides accreditation in areas like testing, calibration, medical testing, and reference material production. Obtaining NABL accreditation benefits laboratories by enhancing customer confidence, reducing re-testing needs, and improving control systems. The process of accreditation involves training, documentation, internal and external audits, and addressing non-conformities before final certification.
The document discusses NABL accreditation, which is provided by the National Accreditation Board for Testing and Calibration Laboratories (NABL) in India. NABL accredits laboratories to ensure they meet technical standards for competence. The accreditation process involves assessments of a laboratory's management system, technical performance, and participation in proficiency testing. Receiving NABL accreditation improves customer confidence and allows access to domestic and international markets by demonstrating a laboratory's technical competence meets international standards.
Priyank Srivastava is a regulatory affairs professional seeking a management position. He has over 7 years of experience in regulatory affairs and quality assurance. Currently he works as a regulatory affairs specialist at Accredited Consultants Private Ltd., where he is responsible for ensuring regulatory compliance and managing product registrations. Previously he worked as Quality Assurance and Quality Control Head at Real Chemsys Products, where he implemented quality systems and oversaw quality control testing. He has expertise in medical devices, drugs, biologicals, and nutraceuticals regulatory requirements in India and other markets.
1. NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. It provides accreditation to technical testing, calibration, medical laboratories, and proficiency testing providers in India.
2. Accreditation through NABL has several benefits, including increased confidence in lab reports, better quality control, and potential business growth. It also allows easier access to both domestic and international markets for users of accredited labs.
3. The NABL accreditation process involves an application, scrutiny of documents, pre-assessment, assessment, and review before accreditation is granted. Laboratories must meet the technical requirements of ISO/IEC 17025 or ISO 15189 and undergo regular audits
Swapnil Kalwatkar has over 13 years of experience in quality assurance and validation roles, currently working as Manager of Validation and Calibration at Indian Immunologicals Limited. He holds an MBA in Pharma Management and M.Pharm in Pharmaceutical Biotechnology, and has worked in validation roles at Dr. Reddy's Laboratories and Wockhardt. The resume provides details of his educational qualifications, work experience, achievements, publications, and personal information.
G.V.S. Ratna Kumar is seeking senior level positions in production, quality, regulatory, research and development with chemical and pharmaceutical companies. He has over 20 years of experience in these areas and most recently worked as the Senior Manager of Production at Malladi Drugs and Pharmaceuticals Limited. He has extensive knowledge of quality standards, cGMP compliance, audits, documentation, and production planning.
NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. This body functions independently under Department of Science and Technology of the Indian Government. NABL is registered via the societies act
This document discusses NABL accreditation, which is a voluntary certification provided by the National Accreditation Board for Testing and Calibration Laboratories (NABL) in India. NABL assesses laboratories for technical competence and provides accreditation in areas like testing, calibration, medical testing, and reference material production. Obtaining NABL accreditation benefits laboratories by enhancing customer confidence, reducing re-testing needs, and improving control systems. The process of accreditation involves training, documentation, internal and external audits, and addressing non-conformities before final certification.
The document discusses NABL accreditation, which is provided by the National Accreditation Board for Testing and Calibration Laboratories (NABL) in India. NABL accredits laboratories to ensure they meet technical standards for competence. The accreditation process involves assessments of a laboratory's management system, technical performance, and participation in proficiency testing. Receiving NABL accreditation improves customer confidence and allows access to domestic and international markets by demonstrating a laboratory's technical competence meets international standards.
Priyank Srivastava is a regulatory affairs professional seeking a management position. He has over 7 years of experience in regulatory affairs and quality assurance. Currently he works as a regulatory affairs specialist at Accredited Consultants Private Ltd., where he is responsible for ensuring regulatory compliance and managing product registrations. Previously he worked as Quality Assurance and Quality Control Head at Real Chemsys Products, where he implemented quality systems and oversaw quality control testing. He has expertise in medical devices, drugs, biologicals, and nutraceuticals regulatory requirements in India and other markets.
1. NABL stands for the National Accreditation Board for Testing and Calibration Laboratories. It provides accreditation to technical testing, calibration, medical laboratories, and proficiency testing providers in India.
2. Accreditation through NABL has several benefits, including increased confidence in lab reports, better quality control, and potential business growth. It also allows easier access to both domestic and international markets for users of accredited labs.
3. The NABL accreditation process involves an application, scrutiny of documents, pre-assessment, assessment, and review before accreditation is granted. Laboratories must meet the technical requirements of ISO/IEC 17025 or ISO 15189 and undergo regular audits
Swapnil Kalwatkar has over 13 years of experience in quality assurance and validation roles, currently working as Manager of Validation and Calibration at Indian Immunologicals Limited. He holds an MBA in Pharma Management and M.Pharm in Pharmaceutical Biotechnology, and has worked in validation roles at Dr. Reddy's Laboratories and Wockhardt. The resume provides details of his educational qualifications, work experience, achievements, publications, and personal information.
G.V.S. Ratna Kumar is seeking senior level positions in production, quality, regulatory, research and development with chemical and pharmaceutical companies. He has over 20 years of experience in these areas and most recently worked as the Senior Manager of Production at Malladi Drugs and Pharmaceuticals Limited. He has extensive knowledge of quality standards, cGMP compliance, audits, documentation, and production planning.
Stabicon specialized in managing product quality process, upgrading and introducing advanced technology into products. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. Established in September 2010. Team experience across from design to concept, lab to commercialization of product and with competent technical experts. Automated process driven and prepared for integration with partner site for transparency and real time access on each application.
Qms NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (...Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to NABL
2. NABL and ISO Principles
3. Need of NABL
4. Recognition of NABL in International Level
5. Scope of NABL
6. Advantages of NABL
Vskills certification for Biopharmaceutical Professional assesses the candidate as per the company’s need for developing and managing biopharmaceuticals. The certification tests the candidates on various areas in types, sources of biopharmaceuticals which also includes methods of production and legal issues.
http://www.vskills.in/certification/Health-Nutrition-and-Well-being/Certified-Biopharmaceutical-Professional
Deputy Manager QA, working exp in beverage, juice water , sauces ketchup, mayonnaise and Jam & new product development. FSMS , HACCP & FSSC implementation& auditing
Nabl calibration PRISM CALIBRATION CENTRE IN AHMEDABADparthiv kinariwala
NABL ACCREDITED CALIBRATION LAB IN AHMEDABAD
PRISM IS NABL APPROVED LAB FOR THERMAL, MECHANICAL AND ELECTRO TECHNICAL FIELD.
PRISM CAN PROVIDE ONSITE CALIBRATION, VALIDATION, ENVIRONMENT SUPPLY AND INSTRUMENT SUPPLY.
NABL accredits testing and calibration laboratories in India to maintain quality and standards. It is governed by the Quality Council of India (QCI) and operates according to international standards ISO/IEC 17011. NABL accreditation provides benefits such as increased confidence in lab reports, recognition both nationally and internationally, and opportunities for continuous improvement and benchmarking. The accreditation process involves application, pre-assessment of the laboratory, feedback and corrective action, and assessment to determine if the laboratory meets the requirements.
1) Prakashkumar Manubhai is seeking a career in regulatory affairs and has over 2 years of experience preparing and submitting drug dossiers for registration in India and international markets.
2) He has a M-Pharma in Drug Regulatory Affairs and Pharmaceutical Management and is well-versed in US, European, and international regulatory guidelines and processes.
3) His most recent role is as an Executive of Regulatory Affairs at Vexxa Life Sciences, where he prepares and reviews dossiers for registration in various Asian and Latin American countries.
The document is a resume for Mira B. Miguel summarizing her work experience and qualifications. She has over 7 years of experience in quality assurance functions, including experience implementing quality management systems and food safety programs. Currently she works as a Quality System Specialist for Wrigley Philippines Inc. where her responsibilities include auditing, supporting quality management programs, and serving as the company's liaison to government agencies. She has a degree in Chemical Engineering and is knowledgeable in quality standards including ISO 9001 and food safety systems.
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.
Vinaykumar P Desai detail job profile- June-2015 for QA QC Technical service...Vinay Desai
Vinaykumar Desai is seeking a position in QA, QC, or technical services with his 28 years of experience in chemical analysis and analytical instrumentation. He currently works as a Technical Services Manager at a large Indian chemicals manufacturer, where he is responsible for product specifications, quality compliance, technical support, and training. Vinaykumar has extensive experience with analytical instrumentation and a strong background in quality systems, including ISO 9001 and the NABL accreditation process.
This document provides an overview of ISO/IEC 17025:2005, which establishes the general requirements for the competence of testing and calibration laboratories. It discusses the key elements of the standard, including management requirements like organization, document control, customer complaints, and corrective/preventive actions. It also covers technical requirements regarding personnel, equipment, sampling methods, measurement traceability, and reporting of results. The benefits of ISO 17025 accreditation are highlighted such as improved quality, customer confidence, marketing advantages, and greater recognition of technical competence.
This document provides guidelines for calibration laboratories seeking accreditation for mechanical measurements. It outlines general requirements for organization, management systems, personnel, facilities, equipment, calibration range and uncertainty, certificates, and proficiency testing. The document defines calibration and measurement capability (CMC) and states that laboratories must comply with requirements in ISO/IEC 17025. It describes maintaining traceability of measurements to national standards and monitoring equipment performance. Laboratories must demonstrate they can achieve their claimed measurement uncertainties.
David O'Halloran has over 15 years of experience in quality assurance and regulatory roles in the pharmaceutical industry. He has held positions such as Director of QA/QC, Quality Assurance Supervisor, and Quality Assurance Associate. He currently works as an independent quality and regulatory consultant helping companies obtain production licenses from Health Canada.
V. L. Kanthachari Pusapati has nearly 20 years of experience in the pharmaceutical industry. He is currently the General Manager of Validation at Sun Pharma Industries, where he leads validation activities across all of Sun Pharma's manufacturing sites globally. Previously, he held roles such as Director of Quality Assurance Validation at Gland Pharma and Hospira Healthcare. He has extensive expertise in validation processes, computer system validation, and ensuring compliance with Good Manufacturing Practices and regulatory requirements.
Fawzy Saad Hassan has over 10 years of experience as a consultant for pharmaceutical, biopharmaceutical, and vaccine projects. He has established quality assurance systems, developed validation master plans, conducted technology transfers, and provided GMP training. He is the executive manager of an international consultancy center and has experience working with companies like GSK, Novartis, Sanofi Aventis, and VACSERA.
Ejaz Shahid has over 30 years of experience in pharmaceutical quality assurance and quality control. He holds a Master's degree in Pharmacy and has worked in senior QA roles for several pharmaceutical companies in Saudi Arabia, Pakistan, and the UAE. Currently he is the Senior Manager of Quality Assurance at Global Pharma in Dubai, where he oversees QA, QC, validation, auditing and ensures compliance with cGMP regulations.
- Pharmalink is a leading independent regulatory affairs specialist founded in 1998 with over 155 staff across offices in Europe, US, India, and Asia-Pacific.
- They provide regulatory solutions and assistance for projects of any scale or duration across the product lifecycle for a range of client types including 18 of the top 20 healthcare companies.
- Case studies provided examples of large, long-term regulatory compliance projects Pharmalink successfully completed for major pharmaceutical companies, bringing hundreds of product licenses and dossiers into compliance through regulatory work.
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.
Gaurav Soni is seeking a position in regulatory affairs with 7 years of experience in pharmaceutical quality assurance and regulatory roles. He currently works as a Senior Research Associate at Intas Pharmaceuticals assisting with batch releases in European countries. Previously he worked at Lupin Limited and Glaxosmithkline Pharmaceuticals. He has experience with dossier preparation, variation submissions, audits, and ensuring compliance with regulations in countries like the US, UK, and Europe. Gaurav holds an M.Pharm degree and provides his resume and details of his qualifications and responsibilities in previous roles.
The document provides a summary of Pramesh Kothari's professional experience and qualifications. It summarizes that he has over 27 years of experience in quality control and management roles in the pharmaceutical industry, including 7 years as Director/General Manager of QC laboratories. He has extensive expertise in analytical techniques and developing, enhancing, and ensuring compliance of quality systems, and has successfully led teams through regulatory audits from the USFDA and other global regulators.
Stabicon specialized in managing product quality process, upgrading and introducing advanced technology into products. We are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business. Established in September 2010. Team experience across from design to concept, lab to commercialization of product and with competent technical experts. Automated process driven and prepared for integration with partner site for transparency and real time access on each application.
Qms NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES (...Dr Ajay Kumar Tiwari
Fundamental knowledge on pharmaceutical
product development and translation from laboratory to market.
Quality management systems: Quality management & Certifications.
1. Introduction to NABL
2. NABL and ISO Principles
3. Need of NABL
4. Recognition of NABL in International Level
5. Scope of NABL
6. Advantages of NABL
Vskills certification for Biopharmaceutical Professional assesses the candidate as per the company’s need for developing and managing biopharmaceuticals. The certification tests the candidates on various areas in types, sources of biopharmaceuticals which also includes methods of production and legal issues.
http://www.vskills.in/certification/Health-Nutrition-and-Well-being/Certified-Biopharmaceutical-Professional
Deputy Manager QA, working exp in beverage, juice water , sauces ketchup, mayonnaise and Jam & new product development. FSMS , HACCP & FSSC implementation& auditing
Nabl calibration PRISM CALIBRATION CENTRE IN AHMEDABADparthiv kinariwala
NABL ACCREDITED CALIBRATION LAB IN AHMEDABAD
PRISM IS NABL APPROVED LAB FOR THERMAL, MECHANICAL AND ELECTRO TECHNICAL FIELD.
PRISM CAN PROVIDE ONSITE CALIBRATION, VALIDATION, ENVIRONMENT SUPPLY AND INSTRUMENT SUPPLY.
NABL accredits testing and calibration laboratories in India to maintain quality and standards. It is governed by the Quality Council of India (QCI) and operates according to international standards ISO/IEC 17011. NABL accreditation provides benefits such as increased confidence in lab reports, recognition both nationally and internationally, and opportunities for continuous improvement and benchmarking. The accreditation process involves application, pre-assessment of the laboratory, feedback and corrective action, and assessment to determine if the laboratory meets the requirements.
1) Prakashkumar Manubhai is seeking a career in regulatory affairs and has over 2 years of experience preparing and submitting drug dossiers for registration in India and international markets.
2) He has a M-Pharma in Drug Regulatory Affairs and Pharmaceutical Management and is well-versed in US, European, and international regulatory guidelines and processes.
3) His most recent role is as an Executive of Regulatory Affairs at Vexxa Life Sciences, where he prepares and reviews dossiers for registration in various Asian and Latin American countries.
The document is a resume for Mira B. Miguel summarizing her work experience and qualifications. She has over 7 years of experience in quality assurance functions, including experience implementing quality management systems and food safety programs. Currently she works as a Quality System Specialist for Wrigley Philippines Inc. where her responsibilities include auditing, supporting quality management programs, and serving as the company's liaison to government agencies. She has a degree in Chemical Engineering and is knowledgeable in quality standards including ISO 9001 and food safety systems.
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.
Vinaykumar P Desai detail job profile- June-2015 for QA QC Technical service...Vinay Desai
Vinaykumar Desai is seeking a position in QA, QC, or technical services with his 28 years of experience in chemical analysis and analytical instrumentation. He currently works as a Technical Services Manager at a large Indian chemicals manufacturer, where he is responsible for product specifications, quality compliance, technical support, and training. Vinaykumar has extensive experience with analytical instrumentation and a strong background in quality systems, including ISO 9001 and the NABL accreditation process.
This document provides an overview of ISO/IEC 17025:2005, which establishes the general requirements for the competence of testing and calibration laboratories. It discusses the key elements of the standard, including management requirements like organization, document control, customer complaints, and corrective/preventive actions. It also covers technical requirements regarding personnel, equipment, sampling methods, measurement traceability, and reporting of results. The benefits of ISO 17025 accreditation are highlighted such as improved quality, customer confidence, marketing advantages, and greater recognition of technical competence.
This document provides guidelines for calibration laboratories seeking accreditation for mechanical measurements. It outlines general requirements for organization, management systems, personnel, facilities, equipment, calibration range and uncertainty, certificates, and proficiency testing. The document defines calibration and measurement capability (CMC) and states that laboratories must comply with requirements in ISO/IEC 17025. It describes maintaining traceability of measurements to national standards and monitoring equipment performance. Laboratories must demonstrate they can achieve their claimed measurement uncertainties.
David O'Halloran has over 15 years of experience in quality assurance and regulatory roles in the pharmaceutical industry. He has held positions such as Director of QA/QC, Quality Assurance Supervisor, and Quality Assurance Associate. He currently works as an independent quality and regulatory consultant helping companies obtain production licenses from Health Canada.
V. L. Kanthachari Pusapati has nearly 20 years of experience in the pharmaceutical industry. He is currently the General Manager of Validation at Sun Pharma Industries, where he leads validation activities across all of Sun Pharma's manufacturing sites globally. Previously, he held roles such as Director of Quality Assurance Validation at Gland Pharma and Hospira Healthcare. He has extensive expertise in validation processes, computer system validation, and ensuring compliance with Good Manufacturing Practices and regulatory requirements.
Fawzy Saad Hassan has over 10 years of experience as a consultant for pharmaceutical, biopharmaceutical, and vaccine projects. He has established quality assurance systems, developed validation master plans, conducted technology transfers, and provided GMP training. He is the executive manager of an international consultancy center and has experience working with companies like GSK, Novartis, Sanofi Aventis, and VACSERA.
Ejaz Shahid has over 30 years of experience in pharmaceutical quality assurance and quality control. He holds a Master's degree in Pharmacy and has worked in senior QA roles for several pharmaceutical companies in Saudi Arabia, Pakistan, and the UAE. Currently he is the Senior Manager of Quality Assurance at Global Pharma in Dubai, where he oversees QA, QC, validation, auditing and ensures compliance with cGMP regulations.
- Pharmalink is a leading independent regulatory affairs specialist founded in 1998 with over 155 staff across offices in Europe, US, India, and Asia-Pacific.
- They provide regulatory solutions and assistance for projects of any scale or duration across the product lifecycle for a range of client types including 18 of the top 20 healthcare companies.
- Case studies provided examples of large, long-term regulatory compliance projects Pharmalink successfully completed for major pharmaceutical companies, bringing hundreds of product licenses and dossiers into compliance through regulatory work.
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.
Gaurav Soni is seeking a position in regulatory affairs with 7 years of experience in pharmaceutical quality assurance and regulatory roles. He currently works as a Senior Research Associate at Intas Pharmaceuticals assisting with batch releases in European countries. Previously he worked at Lupin Limited and Glaxosmithkline Pharmaceuticals. He has experience with dossier preparation, variation submissions, audits, and ensuring compliance with regulations in countries like the US, UK, and Europe. Gaurav holds an M.Pharm degree and provides his resume and details of his qualifications and responsibilities in previous roles.
The document provides a summary of Pramesh Kothari's professional experience and qualifications. It summarizes that he has over 27 years of experience in quality control and management roles in the pharmaceutical industry, including 7 years as Director/General Manager of QC laboratories. He has extensive expertise in analytical techniques and developing, enhancing, and ensuring compliance of quality systems, and has successfully led teams through regulatory audits from the USFDA and other global regulators.
The document is a curriculum vitae for Dr. Zakia Saeed, who has over 15 years of experience in pharmaceutical quality control, quality assurance, and regulatory affairs. She holds a PhD and MPhil in Pharmaceutical Chemistry from Karachi University. Her experience includes positions as Quality Control & Quality Assurance Manager at C.K.D Pharmaceuticals Pakistan and Senior Manager of Quality Assurance & Regulatory Affairs at Medisure Laboratories Pakistan, where she oversaw quality management, inspections, and regulatory compliance. She is skilled in methods validation, documentation, auditing, and ensuring compliance with cGMP standards.
Ghazala Rahim is seeking a quality role that allows her to utilize her expertise in analytical testing and quality control. She has over 15 years of experience in roles of increasing responsibility at pharmaceutical companies. Her experience includes method development and validation, raw material and finished product testing, stability testing, complaint investigation, and ensuring compliance with GMP guidelines. She has strong skills in instrumentation, analytical techniques, method transfers, and training colleagues.
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.
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.
Rajesh Kumar Khandelwal is seeking a position in quality assurance in the pharmaceutical industry. He has over 7 years of experience in QA roles ensuring compliance with regulations like MHRA, TGA, and EU GMP. His experience includes handling deviations, audits, validations, change controls, batch releases and investigations. Currently he works as a Senior Executive of QA for Gracure Pharmaceuticals in Bhiwari, India. Previously he held QA roles at Ind-Swift Ltd., Ankur Drugs Pharma Ltd., and Biogenetic Drugs Pvt. Ltd. handling tasks like compliance monitoring, process validations, and review of manufacturing documents. He has a Bachelor's degree in Pharmacy
1. The document is a curriculum vitae for Mangesh G. Itankar that outlines his work experience and education.
2. Itankar has over 8 years of experience in regulatory affairs and quality assurance roles at pharmaceutical companies like Bayer, Wockhardt, and Tevapharma.
3. He is currently a Senior Regulatory Executive at Bayer where he handles regulatory submissions and maintains licenses and certifications for products in several countries.
Jagadmbay Prasad Singh is a Quality Professional with over 12 years of experience in the pharmaceutical industry. He holds an M.Sc. in Organic Chemistry and a PG Diploma in Applied Analytical Chemistry. His career includes positions at various pharmaceutical companies where he was responsible for quality control, validation activities, audits, and ensuring compliance. He has a strong background in analytical testing and laboratory instrumentation. His goal is to integrate quality guidelines to improve business and patient well-being.
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.
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.
Laboratory and Pharmaceutical Quality Assurance ExpertMathias Atelefack
- The document provides a summary of a laboratory scientist's qualifications and experience over 20 years working in FDA-regulated laboratories in the pharmaceutical and biotechnology industries.
- It outlines his extensive experience overseeing quality assurance/quality control of pharmaceutical manufacturing processes and products, including tablets, capsules, liquids and medical devices.
- Recent roles included providing quality oversight for analytical laboratory operations at a pharmaceutical company, conducting data integrity audits at another pharmaceutical company, and consulting for various pharmaceutical manufacturers on quality assurance issues.
Vipul Patel has over 20 years of experience in pharmaceutical quality control and laboratory management. He is currently an Associate Director of Laboratory Operations at Sun Pharmaceutical Industries in Detroit, Michigan, where he oversees quality control, analytical development, stability testing, and other laboratory functions. Patel has extensive experience ensuring regulatory compliance, leading inspections, and driving continuous improvement in laboratory operations.
G. Ramanjaneyulu has over 11 years of experience in pharmaceutical analysis and documentation in quality control and stability testing roles. He has worked for several major pharmaceutical companies, including Novartis, Micro Labs, Aurobindo Pharma, and Natco Pharma. Currently, he works as a Senior Scientist at Novartis Healthcare in Hyderabad, where he is responsible for method validation, clinical stability projects, documentation, and review of analysis reports and batch releases.
V. L. Kanthachari Pusapati has nearly 20 years of experience in the pharmaceutical industry. He is currently the General Manager of Validation at Sun Pharma Industries, where he leads validation activities across all of Sun Pharma's manufacturing sites globally. Previously, he held roles such as Director of Quality Assurance Validation at Gland Pharma and Hospira Healthcare. He has extensive expertise in validation processes, computer system validation, and ensuring compliance with Good Manufacturing Practices and regulatory requirements.
The document provides a summary of Pramesh Kothari's professional experience and qualifications. It details his 27 years of experience in quality control for pharmaceutical companies, including 7 years as Director/General Manager leading quality control laboratories. It lists his skills in developing and enhancing quality standards, method validations, audits, and releases. His most recent role is as Plant Quality Control Head for Cadila Healthcare, where he is responsible for laboratory establishment, hiring, and more.
Sanjeet Kumar Pandey is a B.Pharma graduate with over 10 years of experience in quality assurance and quality control roles. He is currently working as the Manager of Quality Assurance at Innova Captab Pvt Ltd in Baddi, India. He provides an overview of his work experience, education, technical skills, and personal details in his curriculum vitae.
This document provides a summary of Kamal Jeet Singh's qualifications and work experience. It outlines his educational background which includes an MSc in Chemistry from Guru Jambheshwar University and a BSc from Kurukshetra University. It then details his work experience over the past decade in quality control and assurance roles at various pharmaceutical companies, including his current role as QA Lead at Reckitt Benckiser Healthcare. It also lists his responsibilities, skills and qualifications in areas like documentation control, batch release, audits, and computer skills like SAP.
1. Page 1 of 5
MANOJ KUMAR VERMA Mobile No.: +91 7508606738
Email: manojkverma2003@gmail.com
Overall 13 plus Years of experience including on-site Projects in India and Overseas and
Quality Assurance (QA) of state of the art GMP facilities of Sterile Dosage Forms of Biotech and
Biotherapeutics companies; have faced audits - WHO-Geneva qualification inspection for rec.
Hepatitis B Vaccine, Indian FDA qualification inspection for inactivated viral vaccine against Foot-and-
mouth (FMD) disease, ISO 13485 of British Standards Institute for Medical Devices, CDSCO and
FDA joint Inspection for Cord Blood Banking. CDSCO and Indian FDA joint Inspection for
Erythropoietin (EPO) and Insulin & its analogues (Glargine and Lispro). Applied knowledge of
Quality Systems (QMS), Commissioning & Qualification and Validation. Knowledge of
Regulatory affairs (RA) & GMP regulations as per ICH Q7, USFDA21 CFR part 210 & part 211 &
WHO GMP. Knowledge of General Industry Standards such as ASME BPE & ISPE Baseline
Guides.
Presently, associated with Hyde E & C India Pvt. Ltd., A Biopharma and Pharma
Consulting company, Hyderabad. Other renowned companies worked with are Panacea Ltd.,
Punjab, Lupin Ltd. (Biotech Division), Pune, Maharashtra and Wockhardt Ltd., Waluj,
Aurangabad, Maharashtra.
CAREER OBJECTIVE:
I want to provide my best services to the organization I am associated with by virtue of my knowledge &
experience and to excel in my field of work by consistent efforts.
ACADEMIC PROFILE:
Degree/Level Board/University Division; Marks in
%
Year of
Passing
MBA, Total Quality
Management
Sikkim Manipal University (Distance
Learning Course)
First Division ; 65% 2014
M.Sc. Microbiology
Gurukula Kangri University,
Haridwar, UA, India
First Division ; 64.6 2001
General Certificate Course on Intellectual Property (IP) by Distance learning from WIPO.
POTENTIAL STRENGHTS:
Quick learner and easy adaptability to new methods and systems.
Excellent cross-functional team working and influencing skills.
Capable of leading the team by example to complete the assigned responsibilities within the given
timelines.
Capable of making good decisions and able to resolve problems/issues pertaining to People,
Processor systems without compromising the Quality.
Possess Good communication, presentation and training skills.
2. Page 2 of 5
PROFESSIONAL ACHIEVEMENTS:
On-site Projects in India and Overseas : Commissioning and Qualification of Pharmaceutical
Systems. Qualification of Steam Sterilizer in Shantha Biotechnics Ltd., (a Sanofi company),
Hyderabad, India.
Effective implementation of Quality Management Systems in new Foot and mouth disease Vaccine
plant of B.V. Biologicals, A Division of VHPL, India.
Qualifications, Validations, and effective Implementation of Quality Systems in new Stem Cell
Therapy Plant of Regenerative Medical Service, RegrowR
, Lonavla, Pune and Headed QA Team to
qualify audits - CDSCO and FDA joint Inspection for Cord Blood Banking and BSI ISO 13485 for
Medical Devices.
Active participant in successful Technology transfer (TT) of Hepatitis-B r-DNA Vaccine product from
Heber Unit of Cuba to Panacea Biotec Limited Unit, Lalru, Punjab, India.
Received the Best Presentation award on “Clean room in Pharmaceutical Industry” at Wockhardt
Limited, Aurangabad, Maharashtra, India.
PROFESSIONAL EXPERIENCE:
Hyde E & C India Pvt. Ltd., Hyderabad, A.P., India [27 Oct.’ 2014 to Till Date]
Associated with Hyde E & C India Pvt. Ltd., A US based Biopharma and Pharma Consulting company;
designated as Asst. Manager, Validation. The company is a global design and consulting organization
providing process system design, commissioning and validation, FDA compliance, and state-of-the-art
cleaning technologies to pharmaceutical, bioprocess and other regulated process industries for two
decades.
Job Profile:
1. To organize, manage and execute Commissioning and Qualification of equipment and systems.
2. To manage important Quality Management System elements – Deviation, CAPA and Change
Control.
On-site Projects in India and Overseas during association with Hyde:
1. Shantha Biotechnics Ltd., (a Sanofi company), Hyderabad, India (02 months): Protocol Preparation
and Commissioning & Qualification (C & Q) of Process Equipment and Vessels.
2. Pfizer Ltd. (formerly Hospira Ltd.) (11 months), Visakhapatnam, India: Protocol Preparation and
Commissioning & Qualification (C & Q) of Process Systems and Vessels of Injectable Facilities.
3. Trust Pharma Ltd. (formerly Farmapex Ltd.), Ho Chi Minh, Vietnam (Jan. 25, 2106 to Till Date):
Protocol Preparation and Commissioning & Qualification (C & Q) of Facility and Utility & Process
Systems of Pharmaceuticals and Antibiotics Facilities.
Wockhardt Limited [26 Sep.’ 2011 to 08 August’ 2014 (02 years & 10 months)]
Associated with Wockhardt Ltd., Biotech Park, Waluj, Aurangabad, Maharashtra; designated as Sr.
Executive, QA. The company is engaged in manufacture of Insulin & its analogues (Glargine and Lispro)
and Erythropoietin (EPO) by r-DNA technology.
3. Page 3 of 5
Job Profile:
1. To manage main elements of QMS – OOS, Deviation, CAPA and Change control management.
2. Organizing and coordinating to conduct Self-inspection in GMP Facility.
3. Organizing and coordinating to conduct GMP training of personnel.
4. To review equipment qualification and system validation documents.
Lupin Biotech [27 Feb.’ 2010 – 24 Sep.’ 2011 (01year & 07 months)]
Associated with Lupin Biotech Ltd., Pune, Maharashtra, designated as Executive, QA. Lupin is a
leading transnational Pharma company. It exports its Products in more than 70 Countries. At its present
site the company has got Test License for Biotherapeutics Products - GCSF, PEG-GCSF, interferon-
alpha-2b, Rituximab, Enbrel, IL-11, PTH, PEG-Interferon. Company shall start its commercial batches in
its state-of-the-art GMP facility.
Job Profile:
1. Coordination in Clean room qualification as per ISO 14644 guidelines - Review of Protocol; supervise
the activity for its execution as per Protocol and review of Report.
2. Coordination in System / Equipment (HVAC, Steam Sterilizer, Ultra low temperature freezer, Water
system) Validation/Qualification and Review of Protocols including URS, DQ, IQ, OQ, PQ).
3. Preparation and review of Quality System SOPs of Quality Assurance such as SOP on SOPs,
Organization of Documentation, Deviation Management, CAPA Management, Change control
Management, Self Inspection as per cGMP regulations.
4. Qualification of Vendors / Suppliers / External Test Laboratories.
5. To coordinate in training of personnel working in GMP Facility.
6. Review of Protocol & Reports of Stability of Drug substances and Drug products.
7. Coordination with Regulatory affairs (RA) department to fulfill their documentation requirement from
QA.
Regenerative Medical Services Pvt. Ltd. [02 Sep.’ 2009 – 18 Feb.’ 2010 (06 months)]
Associated with Regenerative Medical Services Pvt. Ltd., Lonavla, Pune, Maharashtra, India;
designated as Manager, QA. The company was engaged in Cord Blood preservation and catering of
Sterile and Processed Autologous Bone cell and Autologous Cartilage cell for Implantation. These are
Technology Transfer Products from Sewon Cellontech, South Korea.
Job Profile:
1. To organize, coordinate and supervise for implementation and Maintenance of Quality system as per
ISO 13485:2003 requirements.
2. Implementation and maintenance of Quality systems as per current Good Manufacturing Practices
(cGMP).
3. Risk Management as per ISO 14971 requirements.
4. Page 4 of 5
B.V. Biologicals, A Division of VHPL [01 Mar’ 2006 – 31 Aug’ 2009 (03 Years and 05 months)]
Associated with M/s B.V. Biologicals, A Division of Venkateshwara Hatcheries Pvt. Ltd., Pune,
Maharashtra, India; designated as the Manager, QA Department. The company was engaged in FMD
Vaccine.
Job Profile:
1. Review of Tier I documents (Quality Manual, Site Master File, Master Formula, Master Validation
Plan), Tier II documents (Protocols, SOPs, Work Instructions) Tier III documents (BMR, BPR,
ATDS).
2. Qualification of Vendors / Suppliers / External Test Laboratories.
3. To recommend release of Batch upon reviewing COAs and documents generated during
Manufacturing.
Panacea Biotec Ltd. [03 Jun’ 2002 – 17 Feb.’ 2006 (03 yrs. and 08 m)]
Associated with M/s Panacea Biotec Ltd. Lalru, Punjab; designated as Senior Scientific Officer in
Quality Assurance (QA) Department of Vaccine manufacturing Unit (a WHO-Geneva pre-qualified).
The company was engaged in Hepatitis B vaccine manufacturing r-DNA technology.
Job Profile:
1. Drafting, preparing and review of Standard operating procedures (SOPs) pertaining to Quality
Assurance Department.
2. To review completed ‘BMR’ submitted by Production Department and
completed ‘Analytical File’ submitted by Quality Control Department for its completeness as per
SOP.
3. To Prepare Product Summary File of reviewed Active Raw Material (Drug substance) and
Finished Product batches as per WHO TRS format.
4. Reviewing Batch related reports (BPR, QC Analytical Report, Utility Report & Environmental
Monitoring Report) and COA (Certificate of Assurance) and recommending for release of finished
product.
TEACHING EXPERIENCE:
Associated with IPER, Pune, Maharashtra, for Two years as a Guest Lecturer to teach topics
on GMP.
COMPUTER SKILLS:
Computer savvy – MS office; SAP and good typing speed on computer.
PERSONAL PROFILE:
Date of Birth : June 12, 1978
Marital Status : Married
Nationality : Indian
Passport No. : M 7711007
Correspondence Address: H. No. 2009/36; Sector 32 C; Chandigarh
5. Page 5 of 5
PIN Code: 160031, INDIA
Permanent Address : H. No. 2009/36; Sector 32 C; Chandigarh
PIN Code: 160031, INDIA
Professional References:
Mr. Vasan Thatai, DGM, QA Department, Wockhardt Limited, Biotech Park, Aurangabad,
Maharasthtra, India. Cell No. +91 70381 24680 ; nasav1@rediffmail.com
Dr. Varsha Govardhan, DGM, QA Department, B.V. Biological, A Division of VHPL, Pune,
Maharasthtra, India. Cell No. +91 95270 67300 ; vgovardhan@hotmail.com ; varshag@vitasci.com ;
www.vitasci.com
Place :
Date : (Manoj Kumar Verma)