An experienced Pharma personnel with Post graduate degree holder in microbiology and having overall 15 plus years of experience of Projects on on-site Commissioning, Qualification and Validation, (CQV) Computer System Validation (CSV) in India and Overseas & Quality Assurance (QA) of Pharma, Biotech and Biopharma companies; Audits faced are 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 Commissioning and Qualification and Validation and Quality Management Systems (QMS). Knowledge of Technology Transfer (TT), GMP regulations as per ICH Q7, USFDA 21 CFR part 210; part 211; part 820, GAMP5, 21 CFR Part 11, EudraLex Volume 4 Annexure 11, Annexure 15 & WHO GMP. Knowledge of General Industry Standards/Guidelines such as ASME BPE, ISPE Baseline Guides, ISO 14644 and PDA. Creation of C&Q (Commissioning and Qualification Documents - URS, DQ, IQ, OQ Protocols of Pharma/Biopharma/Biotech companies and execution of Protocols.