This curriculum vitae summarizes the professional experience of Rajeev Kumar Srivastav. He has over 23 years of experience in quality control roles, primarily in the pharmaceutical industry. He is currently the Head of Quality Control and Microbiology at Aurobindo Pharma Limited. Previously, he has held quality control leadership positions at several major pharmaceutical companies, including Nicholas Piramal India Limited, Unimark Remedies Ltd, and Aurobindo Pharma Limited. He has extensive experience managing quality control teams, implementing quality systems, and preparing for and successfully passing regulatory inspections, including by the US FDA.
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The document discusses guidelines from the International Council for Harmonization (ICH) regarding stability testing of drug substances and products. It provides an overview of the ICH Q1 series of guidelines, which address stability testing, including specifications for testing protocols, storage conditions and minimum data requirements. The guidelines provide recommendations for conducting long-term, intermediate and accelerated stability studies to evaluate the impact of various stress conditions like temperature, humidity and light on drug substances and products. The goal is to ensure quality, safety and efficacy over the proposed shelf-life.
Internship report for pharmaceutical industryRai Waqas
Envoy Pharmaceutical is an ISO certified pharmaceutical company located in Lahore, Pakistan. The internship report summarizes the company's departments and manufacturing processes. Key departments include warehousing, production, and quality control. The production department manufactures tablets, capsules, oral liquids, and injectables using modern equipment according to cGMP standards. Raw materials are received and tested before use. Finished products are packaged and labeled for distribution. The report provides an overview of Envoy Pharmaceutical's operations during the author's internship.
In this slide contains introduction, amendments of FD&C act, HACCP system and different department of USFDA.
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The document discusses current good manufacturing practices (cGMP) for active pharmaceutical ingredients (APIs). It lists major international codes of cGMP such as those from the WHO, EU, US FDA, ISO, and ICH. It also provides references and websites for cGMP standards. The document then discusses topics including validation, validation master plans, qualification types, calibration, facilities, equipment, air handling units, and containment practices.
In this slide contains need of food regulations, system and Legislation Regulation of Food Products as per BSI and Agmark.
Presented by: G. Chiranjeevi (Department of pharmaceutical analysis),
RIPER, anantapur.
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.
EFRAC is an ISO 17025 accredited pharmaceutical testing facility located in Chennai, India. It has 11 regulatory accreditations and conducts a wide range of tests for drugs, cosmetics, and related products according to international standards. EFRAC utilizes cutting-edge technology and qualified instrumentation to provide precise, reliable, and legally defensible testing data to clients.
This document is a resume for Ahmed Adel Abd El Latif Ragab. It summarizes his contact information, education, work experience, courses/certificates, languages, and personal details. He has a Bachelor's in Pharmaceutical Sciences from Alexandria University in Egypt and is pursuing a Master's in Analytical Chemistry and an MBA. His current role is Assistant Quality Control Manager at Pharco Corporation, where he has worked since 2014.
The document discusses guidelines from the International Council for Harmonization (ICH) regarding stability testing of drug substances and products. It provides an overview of the ICH Q1 series of guidelines, which address stability testing, including specifications for testing protocols, storage conditions and minimum data requirements. The guidelines provide recommendations for conducting long-term, intermediate and accelerated stability studies to evaluate the impact of various stress conditions like temperature, humidity and light on drug substances and products. The goal is to ensure quality, safety and efficacy over the proposed shelf-life.
Internship report for pharmaceutical industryRai Waqas
Envoy Pharmaceutical is an ISO certified pharmaceutical company located in Lahore, Pakistan. The internship report summarizes the company's departments and manufacturing processes. Key departments include warehousing, production, and quality control. The production department manufactures tablets, capsules, oral liquids, and injectables using modern equipment according to cGMP standards. Raw materials are received and tested before use. Finished products are packaged and labeled for distribution. The report provides an overview of Envoy Pharmaceutical's operations during the author's internship.
In this slide contains introduction, amendments of FD&C act, HACCP system and different department of USFDA.
Presented by: R.Bhanu Teja (Department of pharmaceutical analysis),
RIPER,anantapur.
The document discusses current good manufacturing practices (cGMP) for active pharmaceutical ingredients (APIs). It lists major international codes of cGMP such as those from the WHO, EU, US FDA, ISO, and ICH. It also provides references and websites for cGMP standards. The document then discusses topics including validation, validation master plans, qualification types, calibration, facilities, equipment, air handling units, and containment practices.
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The document provides information about Arbro Group, a leading manufacturer and exporter of pharmaceutical formulations in India. It has several divisions including manufacturing, research, analytical testing, and training. The Training & Development Division aims to provide quality training programs to develop skilled professionals. It offers various certificate courses on analytical techniques with both theoretical and practical components to prepare students for jobs in the growing analytical chemistry sector. The training programs are supported by the division's world-class analytical laboratory facilities and accreditations.
The document discusses regulations for importing in vitro diagnostic products (IVDs) into India. It explains that IVDs are substances used to diagnose diseases in humans or animals. The Drugs Controller General of India regulates IVD imports to ensure quality, safety and efficacy. IVDs are classified as notified, non-notified, non-critical or semi-critical. Import requirements include application forms, fees, certificates and other documentation depending on the IVD classification. If the application is complete, an import license will be issued within three months. The document provides contact information for Accredited Consultants Private Limited, the organization assisting with IVD imports to India.
Piramal Clinical Trial Services provides clinical trial manufacturing capabilities including packaging, storage, distribution, and reconciliation of investigational drugs. They offer primary and secondary packaging, kit preparation and compilation, temperature controlled storage and distribution, returns management, and support services globally. Piramal aims to offer superior customer service and uses a digital platform called TrakPack to track manufacturing, distribution, returns, and provide reporting to customers.
Bhat Bio-Tech India (P) Ltd was incorporated in the year1994 and carved a niche as the known manufacturers and suppliers of Healthcare products for Malaria, HIV, HBsAg, HCV, Syphilis, Chikungunya, Dengue, LH,hCG Card, Glucometer, Blood Test Strips, Urine Test Strips and many more products. Our products are widely known for the features such as superior quality, reasonable prices. Manufactured from superior quality material our range stands high in terms of quality.
This document provides an overview of key elements and basic principles of Good Manufacturing Practices (GMP). It defines GMP and cGMP, outlines their importance in ensuring product quality and safety, and describes characteristics of GMP-compliant products. The document also summarizes key elements of GMP like personnel, premises, equipment, materials, and quality control. It emphasizes the importance of documentation, validation, recalls, self-inspection, storage and training in adhering to GMP. The objectives of GMP and guidelines from various regulatory bodies are also briefly mentioned.
This document contains the resume of Sudhanshu Tripathi, who has 6 years of experience as a Quality Executive in the food manufacturing industry. He has expertise in quality assurance, quality control, implementing food safety systems like HACCP and ISO 22000. He is seeking a role as a Quality Executive where he can oversee quality operations and ensure compliance with food safety standards. His professional experience includes roles at various food manufacturing companies where he was responsible for quality management, audits, supplier evaluation and ensuring product quality.
This document discusses Good Manufacturing Practices (GMP) for manufacturing investigational medicinal products. It covers the key elements of GMP including quality management, personnel, facilities and equipment, documentation, production, quality control, contracts, complaints and recalls, and self-inspection. GMP aims to ensure products are consistently manufactured and controlled according to quality standards for their intended use. Compliance with GMP is crucial for ensuring quality and safety, especially for medicines that have not been fully tested. Regulators conduct audits to monitor manufacturer compliance.
The presentation deals with the hot issues of regulatory violations made by the Ranbaxy in Mohali plant. It has the violations made and the observations of the FDA inspector, also gives a basic overview of what is form 483 and consent decree. The CAPA I will be uploading soon enough.
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The document discusses the layout of pharmaceutical buildings and services. It begins with an introduction to good manufacturing practices (GMP) and their importance. It then covers the basic requirements for building layout, including material and personnel flows, equipment layout, and ensuring proper process flow. Specific areas of the building are also addressed, including ancillary, storage, weighing, production, and quality control areas. Proper lighting, electricity, and environmental controls are emphasized throughout.
The document provides an overview of quality assurance and related topics presented by Chandrashekhar Jain. It discusses quality assurance, the USFDA, WHO guidelines, and ISO 9000 standards. Key points include that quality assurance ensures pharmaceutical products meet quality standards for intended use, the USFDA regulates food, drugs, and other products, WHO sets global health standards and provides technical support to countries, and ISO 9000 provides internationally recognized quality management system guidelines.
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.
This curriculum vitae summarizes Tanveer Ahmed's qualifications and experience in quality assurance. He has over 10 years of experience in quality assurance, validation, and quality control, working for several pharmaceutical companies in Bangladesh. His experience includes international regulatory inspections and working with an FDA consultant. He held positions such as Quality Assurance Manager and QA In-Charge. He has a Bachelor of Pharmacy degree and training in topics such as quality management, EU GMP guidelines, cleaning validation, and sterile facility operation.
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.
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.
Indian regulatory requirements - industrial pharmacy 2Jafarali Masi
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs
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.
The document provides information about Arbro Group, a leading manufacturer and exporter of pharmaceutical formulations in India. It has several divisions including manufacturing, research, analytical testing, and training. The Training & Development Division aims to provide quality training programs to develop skilled professionals. It offers various certificate courses on analytical techniques with both theoretical and practical components to prepare students for jobs in the growing analytical chemistry sector. The training programs are supported by the division's world-class analytical laboratory facilities and accreditations.
The document discusses regulations for importing in vitro diagnostic products (IVDs) into India. It explains that IVDs are substances used to diagnose diseases in humans or animals. The Drugs Controller General of India regulates IVD imports to ensure quality, safety and efficacy. IVDs are classified as notified, non-notified, non-critical or semi-critical. Import requirements include application forms, fees, certificates and other documentation depending on the IVD classification. If the application is complete, an import license will be issued within three months. The document provides contact information for Accredited Consultants Private Limited, the organization assisting with IVD imports to India.
Piramal Clinical Trial Services provides clinical trial manufacturing capabilities including packaging, storage, distribution, and reconciliation of investigational drugs. They offer primary and secondary packaging, kit preparation and compilation, temperature controlled storage and distribution, returns management, and support services globally. Piramal aims to offer superior customer service and uses a digital platform called TrakPack to track manufacturing, distribution, returns, and provide reporting to customers.
Bhat Bio-Tech India (P) Ltd was incorporated in the year1994 and carved a niche as the known manufacturers and suppliers of Healthcare products for Malaria, HIV, HBsAg, HCV, Syphilis, Chikungunya, Dengue, LH,hCG Card, Glucometer, Blood Test Strips, Urine Test Strips and many more products. Our products are widely known for the features such as superior quality, reasonable prices. Manufactured from superior quality material our range stands high in terms of quality.
This document provides an overview of key elements and basic principles of Good Manufacturing Practices (GMP). It defines GMP and cGMP, outlines their importance in ensuring product quality and safety, and describes characteristics of GMP-compliant products. The document also summarizes key elements of GMP like personnel, premises, equipment, materials, and quality control. It emphasizes the importance of documentation, validation, recalls, self-inspection, storage and training in adhering to GMP. The objectives of GMP and guidelines from various regulatory bodies are also briefly mentioned.
This document contains the resume of Sudhanshu Tripathi, who has 6 years of experience as a Quality Executive in the food manufacturing industry. He has expertise in quality assurance, quality control, implementing food safety systems like HACCP and ISO 22000. He is seeking a role as a Quality Executive where he can oversee quality operations and ensure compliance with food safety standards. His professional experience includes roles at various food manufacturing companies where he was responsible for quality management, audits, supplier evaluation and ensuring product quality.
This document discusses Good Manufacturing Practices (GMP) for manufacturing investigational medicinal products. It covers the key elements of GMP including quality management, personnel, facilities and equipment, documentation, production, quality control, contracts, complaints and recalls, and self-inspection. GMP aims to ensure products are consistently manufactured and controlled according to quality standards for their intended use. Compliance with GMP is crucial for ensuring quality and safety, especially for medicines that have not been fully tested. Regulators conduct audits to monitor manufacturer compliance.
The presentation deals with the hot issues of regulatory violations made by the Ranbaxy in Mohali plant. It has the violations made and the observations of the FDA inspector, also gives a basic overview of what is form 483 and consent decree. The CAPA I will be uploading soon enough.
Layout of pharmaceutical building and servicesHimal Barakoti
The document discusses the layout of pharmaceutical buildings and services. It begins with an introduction to good manufacturing practices (GMP) and their importance. It then covers the basic requirements for building layout, including material and personnel flows, equipment layout, and ensuring proper process flow. Specific areas of the building are also addressed, including ancillary, storage, weighing, production, and quality control areas. Proper lighting, electricity, and environmental controls are emphasized throughout.
The document provides an overview of quality assurance and related topics presented by Chandrashekhar Jain. It discusses quality assurance, the USFDA, WHO guidelines, and ISO 9000 standards. Key points include that quality assurance ensures pharmaceutical products meet quality standards for intended use, the USFDA regulates food, drugs, and other products, WHO sets global health standards and provides technical support to countries, and ISO 9000 provides internationally recognized quality management system guidelines.
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.
This curriculum vitae summarizes Tanveer Ahmed's qualifications and experience in quality assurance. He has over 10 years of experience in quality assurance, validation, and quality control, working for several pharmaceutical companies in Bangladesh. His experience includes international regulatory inspections and working with an FDA consultant. He held positions such as Quality Assurance Manager and QA In-Charge. He has a Bachelor of Pharmacy degree and training in topics such as quality management, EU GMP guidelines, cleaning validation, and sterile facility operation.
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.
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 is a resume submitted by Dr. Raman Deep Kumar Singh for a job opportunity. It summarizes his educational qualifications including a Ph.D from Dr. Hari Singh Gour University, and over 8 years of experience in quality control for pharmaceutical companies. His experience includes stability testing, method validation and transfer, instrument calibration, and successfully interacting with regulatory agencies like USFDA, MHRA, and others. He is currently working as Assistant Manager of Quality Control at Sava Health Care Ltd and is seeking new opportunities that allow career growth and expanding his knowledge and skills.
Quality Auditor and trainerProfile-G.sundarG Sundar
The document provides a curriculum vitae for G.Sundar outlining his 22 years of experience in quality assurance and regulatory compliance roles. It details his expertise in areas such as GMP, GLP, ISO standards, equipment and process validation, auditing, and preparing for regulatory inspections. It also lists recent regulatory audits he has faced, including multiple successful USFDA inspections, and audits he has conducted of API and formulation manufacturing sites.
This document is a resume for Ahmed Adel Abd El Latif Ragab. It summarizes his contact information, education, work experience, courses/certificates, languages, and personal details. He has a Bachelor's in Pharmaceutical Sciences from Alexandria University in Egypt and is pursuing a Master's in Analytical Chemistry and an MBA. His current role is Assistant Quality Control Manager at Pharco Corporation, where he has worked since 2014.
Snehlata S Helambe is seeking a position in the pharmaceutical industry to further develop her skills. She has 5 years of experience in sterile pharmaceutical formulation and quality control. Currently she works as an executive at Baxter India where her responsibilities include analytical testing, calibration of instruments, defect reporting, and stability studies. Previously she worked at Hospira Healthcare India where she prepared and reviewed standard operating procedures, handled change controls, and performed product analysis. She has a Master's degree in pharmaceutical chemistry and a Bachelor's degree in pharmacy.
R.D.PRABHAKARA REDDY is seeking assignments in pharmaceuticals with over 16 years of experience in quality assurance for APIs. He currently works as Assistant General Manager of Quality Assurance at Srikar Laboratories Pvt Ltd. He has strong understanding of GMP guidelines and experience handling inspections from regulatory bodies like US FDA, UK MHRA, and Australian TGA. He is experienced in supplier audits, compiling dossiers, and ensuring compliance with global regulatory requirements for markets like US, EU, Japan and Canada.
Abhra Chandra is a Quality Assurance professional currently working at LIFEPharma FZE Dubai, UAE. He has over 8 years of experience in quality assurance roles. His responsibilities include vendor qualification, annual product quality reviews, implementation of SAP systems, internal auditing, training employees, document control, and batch record review. Previously he worked at Symbiotic Pharmalab and ESKAG PHARMA in quality assurance roles focused on batch record review, environmental monitoring, cleaning validation, and process validation. He holds an M.Pharm degree from Siksha ‘O’ Anusandhan University and a B.Pharm degree from West Bengal University of Technology.
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.
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.
PVRSN Reddy has over 20 years of experience in quality control and laboratory roles in the pharmaceutical industry. He holds a BSc and MSc in Chemistry and is proficient in MS Office applications. His career history includes positions as Quality Control Manager and Analyst at various pharmaceutical companies in India and Malaysia, where he gained experience across tablets, capsules, pellets and other drug forms. He has strong skills in chemical and instrumentation analysis, documentation, and ensuring compliance with regulatory standards.
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.
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.
Narender Adepu is seeking a challenging position in quality with over 14 years of experience in the pharmaceutical industry. He holds an M.Sc. in Chemistry and has worked in quality control roles at various pharmaceutical companies. His responsibilities have included ensuring compliance with ICH, USFDA, and EU guidelines; method validations; stability studies; and handling audits. He is proficient in various laboratory software and analytical instruments and seeks to advance his career as a quality auditor.
Narender Adepu is a highly qualified and experienced Quality professional seeking a manager position in Quality. He has over 14 years of experience in Quality for API and pharmaceutical manufacturing. He holds an M.Sc. in Chemistry and has worked for several major pharmaceutical companies in various Quality roles, managing laboratories and leading audits. His technical skills include proficiency with GMP/GLP systems and analytical instrumentation.
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.
Ajay Kumar has over 10 years of experience in the pharmaceutical quality assurance field. He has a background in process validations, cleaning validations, vendor qualifications, audits, and compliance management. Currently, he works as an Assistant Manager of Quality Assurance at Jubilant Generics Limited in Roorkee, where he handles activities such as cleaning validation, process validation, vendor management, and investigations. He has a B.Pharmacy degree from A.A.I-Deemed University and experience working with various pharmaceutical companies in both management and analytical roles.
1. 1
CURRICULUM VITAE
RAJEEV KUMAR SRIVASTAV
205, Sri Sai Dtta Apartment,Kompally,
RR Dist. Secunderabad-500014
Telangana (India)
E Mail : rajeevsrivastav65@yahoo.co.in
rajeevsrivastav1965@gmail.com
Mobile No: 08498052259,09949364347
Application for the post of: DGM /GM – Quality Control (API/Bulk Drug)
FDA approval -- Approved by Food & drug administration, Bhopal, (MP)
OBJECTIVE:
Seeking a suitable position in quality function of an esteemed organization, where my
Managerial, analytical and Leadership skills can be put for the growth of the organization.
PERSONAL DETAILS:
Father’s name : Sri Birendra Kumar Srivastav
Date of birth : 01-01-1965.
Languages : Hindi & English.
Martial status : Married.
Nationality : Indian.
Passport No : J7849081
EDUCATIONAL QUALIFICATIONS:
1979 – Matric (X) Full time course, Second class, 54% marks.
1981 – I. Sc. (XII) Full time course, Second class, 48% marks.
1985 – B.Sc. (Chemistry Hons) Full time course, Second class, 59% marks.
1989 – M.Sc. (Organic Chemistry) Full time course, Second class, 57% marks.
1992 – LL.B(Taxation & Administration Laws) Full time course, Second class,57% marks
AUDIT FACED:
Faced "USFDAaudits" in Srini Pharmaceuticals Limited, Nicholas Piramal India Limited
& Different locations of Aurobindo Pharma Limited. (More than 12 USFDA Audits)
2. 2
# Current "USFDAaudits" faced directly/indirectly across APIs Units (10 Units) of
Aurobindo Pharma Limited, even one day prior notice and got success:
Research Centre II:
1. USFDA Investigator: Mrs.Parul Patel (During July 23 rd
to July 26 th
, 2013)
2. USFDA Investigator: Mr.Marvin D Jones (During Dec 3 rd
to Dec 6 th
, 2015)
Unit V: USFDA Investigator (Mr. Larry K Austin) (During Oct 7 th
to Oct 11 th
, 2013)
Unit I: USFDA Investigator (Mr.Kham Phommachanh) (During Nov 18 th
to Nov 22
nd
2013)
Unit VIII: USFDA Investigator (Mr. Michal Goga) (During April 14 th
to April 18 th
,
2014)
Unit VI: USFDA Investigator (Mrs. Yumi Hiramine) (During Dec 2 nd
to Dec 9 th
,
2014)
Unit IX: USFDA Investigator (Mr. Bogdrad Zachary) (During March 2 nd
to March 5
th
, 2015)
Unit XI: USFDA Investigator (Mrs. Bonita Chester) (During April 27 th
to April 30 th
,2015)
Faced USFDA,TGA,MHRA,ANVISA,KFDA,AGES,COFEPRIS,PMDA, CDSCO,
WHO- GMP, ISO 9001-2008 & 19011-2002,14001 audits in Nicholas Piramal India
Limited & Aurobindo Pharma Limited
Faced "WHO GMP audit" in Aristo Pharma Limited, Nicholas Piramal India Limited
& Aurobindo Pharma Limited.
Faced more than 1000 customer audits in Nicholas Primal India Limited, Unimark
Remedies Ltd & Aurobindo Pharma Limited.
TRAINNING / WORKSHOP / APPRECIATION:
Under one year external training for Bullet Proof Managers.
Trained (during 2 day’s work shop) on Leadership and awarded certificate by
Aurobindo Pharma Ltd..
Trainined for implementation of LIMS (Going for implementation of LIMS across all
Units of API division)
Trained (during 2 day’s work shop) on Inter Units Audits by
Aurobindo Pharma Ltd.
Trained (during 1 days work shop) on "Brain Storming programme" for
Improving plant efficiency and reducing manufacturing cost and awarded
Certificate by Unimark Remedies Ltd.
Trained (during 1 day work shop) on "Good Titration Practice" and awarded
Certificate by Mettler –Toledo.
Trained (during 2 day’s work shop) on Practical “Internal auditing of Quality
Management systems" as per ISO9001-2008 and 19011-2002 and awarded
Certificate.
Trained (during 2 day’s work shop) on how to "Train the Trainer" and awarded
certificate.
Trained (during 2 day’s work shop) on" HAZOP" and awarded certificate.
Awarded certificate by Nicholas Piramal India Limited for Higher capacity
Utilization & Productivity.
Awarded certificate by Nicholas Piramal India Limited for “MISSION USFDA".
TOTAL EXPERIENCE:
About 23 Years only in Quality Control (Chemical / Instrumental / Microbiology)
3. 3
Aurobindo Pharma Limited, Unit I, Borapatla, Hyderabad.
A Public Ltd. company, having more than 2 Billion turnover, Bulk drug/API manufacturer &
EOU. Certified with ISO 9001-2008, 14001, WHO-GMP, ANVISA, TGA, MCC, MHRA, CDSCO,
KFDA, COFEPRIS, PMDA Japan, AGES & USFDA etc.
Deputed as HOD - Quality Control and Microbiology, Since 1 st
March, 2016.
(In APL total about 4 Years only)
. Nature of work: Reporting to.GM - CQC, Leading /working with about 250 no’s Analysts/QC
team & Microbiology team.
Aurobindo Pharma Limited, Corporate Office, Hyderabad, Telangana (India).
A Public Ltd company, having more than 2 Billion turnover, Bulk drug/API manufacturer &
EOU. Certified with ISO 9001-2008, 14001, WHO-GMP, ANVISA, TGA, MCC,
MHRA,CDSCO,KFDA,COFEPRIS,PDMA Japan, & USFDA etc.
As Senior Manager – CQC, Since 10 th
April, 2013 to continue
Nature of work: Reporting to.GM - CQC, Working with about 40 No’s Lab
Compliance/ GLP team at 10 different Bulk drug/API locations.
Having good knowledge of QMS.
Auditor of Inter Units Audits conducted by CQA.
Responsible for Lab Compliance, Audit & Compliances and to get maintained all Units
(Chemical/Instrumental/Microbiology) Laboratories auditable with respect to Data
Integrity, 21 CFR Part 11, Disaster Management (Back up related activityof
Empower3/Lab solution Server& Stand alone Software’s connected to all analytical
Instruments),Audit Trails review ,OOS,OOT,OOC,Lab Incidents’, Cost
reduction,Centralised decision & procurement of all QC related Infrastructure/ Instruments
/Spares/Chemicals etc.
Harmonization & Implementations of centralized SOPs, STPs, GTPs etc
Location wise establishment of new Laboratories and updation of Infrastructure of
lab.Requitment of Man Power & procurement of Instruments & Equipments as per
Budget for all APIs units against capex approval.
Aurobindo Pharma Limited, Unit XI, Vishakapatnam, Andhra Pradesh (India).
A Public Ltd company.,having more than 2 Billion turnover, Bulk drug/API
manufacturer & EOU,Certified with ISO 9001-2008, 14001, WHO-GMP, ANVISA, TGA,
MCC, MHRA,CDSCO,KFDA,COFEPRIS,PDMA Japan, & USFDA etc.
As Manager – QC / GLP & Microbiology Since 09 th
July, 2012 to 10 th
April, 2013
. Nature of work: Reporting to DGM - QC, Worked with about 320 QC Eemployees in addition
to Q.C.related supervision for Sampling, analysis of different Raw Materials, In process,
Intermediates, APIs and Packaging materials and dispatch.
Leading a GLP team of about 20 members and Microbiology team about 16 no’s in addition to
Service Engineers.Resposible for any NC and maintaining the Lab auditable with respect to 21
CFR Part 11 related activity, Administrator of all Instruments, Backup activity of
Empowr3 /Class Agent Server, Data Integrity, Audit Trail,Preventive Maintenance &
Calibration of all analytical Instruments, Preparation of SOP, STP, GTP,Protocols etc
IQ,OQ,PQ preparation, Audit & Compliance,OOT,OOS & Lab incident investigation, Change
control & Deviations, PQ of Refrigerator, Calculator,Laboratory, Retentation sample rooms and
4. 4
others, Documentation, Document control & review, Working standard management, Analyst
qualification, training activity (introductory, facility, instrumrnts, guidelines & regulatory
related),Analytical method,Cleanning method & Excel sheet Validation, Stability related,
coordination with CRA, CQA, ARD, R&D, Purchase, Instrument service Engineers & Marketing.
Experience to establish 5 No’s new QC Laboratories related to APIs etc.
Unimark Remedies Ltd. Ahmadabad, Gujarat
A joint venture with HIKMAPharmaceuticals, Europe US/North Africa (MENA).
A Bulk drug/API / Penem Sterile mixture manufacturer, certified by USFDA, EDQM,
WHO, 14001 & OSHAS etc
Worked as HEAD (Manager) – Quality Control and Microbiology, Since 9 th
June,
2011 to 30 th
June, 2012.
Overall responsible for APIs (Penem & Cephalosporins), Sterile APIs mixture
related QC & Microbiology.
Reporting to Sr. VP- Corporate Quality, worked with more than 60 No’s
QC / Microbiology Employees.
API Products: Imipenem, Meropenem, Ertapenem, Cilastatin Sodium, Cefaclor,
Cefprozil Monohydrate, 7ACCA etc
API Sterile Products:Imipenem, Meropenem, Cilastatin Sodium, Sodium
bicarbonate , Sodium carbonate, Sterile mixture of Imipenem & Cilastatin Sodium etc
Aurobindo Pharma Limited, Unit I, Borapatla, Hyderabad.
A Public Ltd. company, having more than 1 Billion turnover, Bulk drug/API manufacturer &
EOU. Certified with ISO 9001-2008, 14001, WHO-GMP, ANVISA, TGA, MCC,
MHRA,CDSCO,KFDA, COFEPRIS,PMDA Japan, & USFDA etc.
As Dy. Manager – Quality Control & GLP. Since 13 th
May, 2008 to 30 th
May 2011(About 3
Years only)
Nature of work: Reported to AGM - QC,
Worked with about 220 QC employees in addition to QC/Microbiology related supervision
for Sampling, analysis & dispatch of different Raw Materials, In process, Intermediates,
APIs and Packaging materials. Leaded a GLP team of about 20 members in addition to
service Engineers and maintaining the Lab auditable with respect to 21 CFR Part 11
related activity, Administrator of Water Empowr 2 server, Review of Audit Trails/Data
integrity, Disaster Management, Preparation of SOP, STP, GTP, Preventive Maintenance
review and documentation, IQ,OQ,PQ preparation of all Instruments, Audit &
Compliance,OOT,OOS,OOC investigation, Lab incident,Change control & Deviations,
Analytical method adoption from ARD, PQ of Refrigerator, Calculator Control sample rooms
and others,Documentation, Document review, control & retrival, working standard management,
Calibration and preventive maintenance of all QC related Instruments, Analyst qualification,
training activity (introductory, facility, instruments, guidelines & regulatory related),Analytical
method,Cleanning method & Excel sheet Validation, Stability related, Coordination with CRA,
CQA, ARD, R&D, Purchase, Instrument service Engineers & Marketing.
Knowledge to establish new Lab facility etc.
Nicholas Piramal India Limited, Digwal, Hyderabad. A Bulk drug API Manufacturer, A
Custom Manufacturing Unit ,100% EOU, certified with ISO 9001-2000, WHO, 14001,
MHRA,TGA,ANVISA & USFDA etc.
As Executive - Q.C (Equivalent to Asst. Manager) Since 27 th
January, 2006 to 28 th
April, 2008. (2 Years & 3 months only )
Reporting to VP- Quality
5. 5
Nature of work: Lead as Finished product In charge of Q.C.which was Rohedia UK Patent
Anesthetic products (e.g.Sevoflurane, Halothane & Isoflurane) with about 60 no Chemists &
Executives up to world wise dispatch SOP, STP, GTP, IQ, OQ, PQ preparation
documentation, document review, SAP related activity, Working standard management,
Calibration, 21 CFR part 11 Management etc.
From sampling and analysis of Raw materials, Packaging materials and finished products in
addition to World wise dispatch to 80 Countries.
Member of packaging development team of Nicholas Piramal Group.
API Products: Verapamil Hydrochloride, Levobunolol Hydrochloride, Ibuprofen,
Ketoconazole, Diltiazem Hydrochloride, Chloropurine, Promethazine,Cis (+) Hydroxyl lactam,
Halothane, Isoflurine, Sivaflurine,Disflurine & lot of customer products.
Srini Pharmaceuticals Limited, Hyderabad.(A joint venture with APOTEX INC., Canada.)
A Bulk drug (API) manufacturer,100% exports oriented Unit certified with USFDA, TGA,ISO
9001-2000, WHO, 14001 etc.
As Senior Executive - Q.C. since 25 th
October 2003 to 25 th
January 2006
(About 2 Years & 3 Months only)
Nature of work: In charge of in process & Raw materials with more than 25 no’s Analysts and
reported to Manager-QC. Supervision for sampling, Instruments Calibration, Volumetric
solutions preparation & standardization, Cleaning validation,Water samples Validation &
analysis, SOP, STP, GTP preparation, documentation, document review for FDA audit etc.
Bajaj Consumer care Limited (Health care division of bajaj group) Hyderabad.
As HEAD (Asst. Manager) - Q.C Since 6 th
December 2000 to 23 rd
Oct 2003(About 2 years &
10 months)
Nature of Work: Quality Control Head: Lead as over all QC In charge with about 10 no’s
Analysts and reporting to Works Manager/GM.
Cure worth (India) Limited, ( A Unit of Uniworth International group) Chhindwara (M.P) A
Bulk drug (API) manufacturer,
Lead as Shift In Charge/Executive (Second In charge of QC) with about 25 no’s Analysts and
reporting to Asst. Manager - QC. Since 4th
September 1995 to 4 th
December 2000(About 5
Years & 3 months)
Nature of Work:
(As per GMP Norms) Chemical and Instrumental analysis of RM, In process Intermediate
products & Finished goods in addition to all Q.C. activity (e.g. dispatch, documentation, Vender
samples approval, blending decision to dispatch of FP,SOP,STP,GTP preparation, document
review, resolve Customer complain & FDA related works etc.)
Products: Pefloxacin, Norfloxacin, Ciproflaxacin & Cephalexin.
Aristo Pharmaceuticals Limited, Mandideep, Raisen, M.P. (Pharmaceutical
Formulation) As a Q.C. Jr. Chemist since 16th
June 1993 to 2nd
September 1995.
(2 Year & 3 months)
Nature of Work: (As per W.H.O norms) Analysis of RM, IP, FP and PM, SOP, STP preparation,
Documentations etc, related to Oral formulation (Tablet, Capsule, Syrup, Dry
Syrup, Suspension, Granules and Ointments etc.)
KNOWLEDGE OF INSTRUMENTS: HPLC, HPTLC, GCHead Space GC, FTIR Spectrometer,
NIR Spectrometer, UV/VIS Spectrometer, Polarimeter,IC,DSC,TOC Analyser, ICPOES, MP
apparatus, KF Apparatus, Moisture meter, Auto potentiometer titrator,pH/TDS/Conductivity Mater,
6. 6
Particle size analyzer / Master Seizer, Sieve Analyzer, Tap density tester, Bursting strength
apparatus, Vernier caliper, Screw gauge, Tablet hardness tester,DT, Friability & Leak test
apparatus etc.
STRENGTHS:
1. Open to learn new things. Strong work ethics, discipline and self motivated.
2. Committed to strive in achieving the goals.
3. Proficient in delivering timely and productive results in tight deadlines.
4. Good motivator of the self and team under all the circumstances.
5. Maintain good relations with the cross functional teams.
6. Having excellent capability to trained down the lines technically with respect to work in
current scenario.
Salary drawing (CTC) : Total about 15 Lakhs PA
Salary expected : About 20 Lakhs PA
Notice period : 03 Months only (But can be relive earlier as per consent of HOD
& HR or on paying money against early reliving days)
PLACE: Kompally, Secunderabad
DATE: 30/07/2016
(RAJEEV KUMAR SRIVASTAV)
References:
1. My present Boss: Dr. Satyendranath Chakkirala
GM-CQC, Aurobindo Pharma Limited, Hyderabad
Mobile No - 8096555323, E Mail address – satyendranath.chakkirala t@aurobindo.com
2. Ex. Boss: Mr. Navin Kumar Agarwal
AVP-Corporate Quality, Sun Pharma Industries, Vadodara
Mobile No. - 7573010631, E Mail address – navinchery1@yahoo.co.in
3. Ex. Boss: Mr.BVSNS Sastry,
Sr. VP - CQA, Aurobindo Pharma Limited, Hyderabad
Mobile No. - 505505945, E Mail address – sbvsns @yahoo.com
4. Ex Boss Mr. Sunil Deshmukh
Sr. VP – QA (Presently Manufacturing)
Piramal Health Care Limited, Digwal, Hyderabad,
Mobile No - 9849201026, E Mail address – sunil.deshmukh1@pirramal.com
5. First Boss Mr. Vinay Verma
VP – Quality, Sun Pharma Industries, Devas, Indore,
Mobile No - 9755540707,
6. Dr.Hemanth Sharma
Sr. VP – ARD, Research Centre II,Aurobindo Pharma Limited, Hyderabad,
Mobile No - 8455223720, E Mail address – hemant@aurobindo.com