ANAND KUMAR GAUTAM
Quality Assurance (Qualification)
Jaunpur
Summary
To involve in some innovative work that will put my knowledge to practical use, broaden the horizons of my skills and understanding and contribute towards the organizational goal.
Overview
1
1
Language
13
13
years of professional experience
Work History
Assistant Manager
Zydus Lifesciences Limited, Ahmedabad DEPARTMENT: Q.A. – Qualification (Parenteral)
07.2021 - Current
- Working in qualification department of Sterile oncology injectable facility (Liquid, Powder and Lyophilized product).
- Qualification for Greenfield project of new line installation of Make: IMA, Italy.
- Qualification of injectable equipment, i.e., Isolator, VHP Generator, Vial washing, Tunnel,Filling, Capping, External vial washing, Lyophilizer, Automatic loading-unloading machine for Lyophilizer, Autoclave, Glove integrity tester.
- Cycle development & validation activities of VHP cycle of Isolator.
- Qualification of HEPA & Utility.
- Managing temperature mapping study of area and equipment like stability chambers, incubators.
- Computer system validation of equipments & software.
- Transport validation study of products.
- Qualification of visual inspectors & service providers.
- Risk assessment review of facility, equipment, utilities and operations.
- To prepare, review and revise Validation master plan, Site master plan and Quality manual.
- Operation of Kaye thermal validation system, Temperature and RH data logger, Calibration instrument.
- Responsible for Compliance, self inspection & training.
- Review of SOP, Audit trail, Calibration and Preventive maintenance activities.
- Developed and implemented new strategies and policies.
Sr. Executive
CIPLA Limited DEPARTMENT: Microbiology – Formulation.
01.2015 - 06.2021
- Conducted sterility tests on pharmaceutical products using validated open and closed system methods to ensure product safety.
- Performed microbiological limit testing of raw materials, finished products
- Analytical review of water testing results, ensuring compliance with GMP and regulatory requirements.
- Routine environmental monitoring of cleanrooms and production areas, including air, surface, and personnel sampling, in compliance with GMP and ISO standards.
- Prepared culture media (solid and liquid) for microbiological testing, ensuring accuracy and sterility in accordance with pharmacopeial standards.
- Growth promotion tests to confirm sterility and growth-supporting properties of prepared media.
- Preparation and reviewed layout justification documents for production facilities, ensuring optimal workflow, contamination control, and regulatory compliance.
- Supervised laboratory operations, reviewed test results, and ensured adherence to GMP and regulatory standards.
- Verified biological indicators through enumeration testing to ensure effectiveness of autoclave and sterilization processes.
- Validated analytical methods for microbiological examination of non-sterile products.
- Validated microbiological methods (MLT, sterility, water analysis) and trained team members to ensure compliance with GMP and pharmacopeial standards.
- Developed work plans and schedules to meet project deadlines while maintaining compliance with GMP and organizational standards.
Research Analyst
Institute of Medical Sciences Banaras Hindu University, Varanasi U.P.
02.2013 - 12.2014
- Plant Growth Promoting Rhizobacteria (PGPR).
Education
M.Sc. - Microbiology
V.B.S. Purvanchal University Jaunpur U.P.
Jaunpur, U.P.01-2012
B.Sc. -
R.S.K.D.P.G. College Jaunpur
Jaunpur, U.P.01-2010
H.S.C. -
Shiya Inter College Jaunpur
Jaunpur, U.P.01-2007
S.S.C. -
Shiya Inter College Jaunpur
Jaunpur, U.P.01-2005
Skills
Successfully faced audits conducted by USFDA, WHO, CQA, SQA, EAGLE, and CAC, ensuring compliance with global regulatory standards
Experienced in equipment and facility qualification (IQ, OQ, PQ), ensuring validated performance and regulatory compliance
Actively participate in QMS activities, Documentum, LIMS, Validator & ZYTIMS
Strong ability to work in a group, contributing to collective problem-solving and achieving project goals
trong analytical and problem-solving abilities, applied to resolve technical and operational challenges in microbiological testing and quality assurance
Timeline
Assistant Manager
Zydus Lifesciences Limited, Ahmedabad DEPARTMENT: Q.A. – Qualification (Parenteral)
07.2021 - Current
Sr. Executive
CIPLA Limited DEPARTMENT: Microbiology – Formulation.
01.2015 - 06.2021
Research Analyst
Institute of Medical Sciences Banaras Hindu University, Varanasi U.P.
02.2013 - 12.2014
M.Sc. - Microbiology
V.B.S. Purvanchal University Jaunpur U.P.
B.Sc. -
R.S.K.D.P.G. College Jaunpur
H.S.C. -
Shiya Inter College Jaunpur
S.S.C. -
Shiya Inter College Jaunpur