A Pharma professional with post graduate degree holder in microbiology and having overall 15 plus Years of experience of QA & Validation of Manufacturing companies and of Projects on on-site Commissioning, Qualification and Validation (CQV), in India and Overseas 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, GAMP 5, 21 CFR Part 11, EudraLex Volume 4 Annexure 11, Annexure 15 & WHO GMP. Preparation, Reviewed and Updation of GMP Documents - Tier I document (Quality Manual, Site Master File, Master Formula, Master Validation Plan), Tier II documents (Protocols, SOPs, Work Instructions) Tier III documents (BMR, BPR).