Rohit Purake
Manager-CQA| Quality Auditor at P&G | NSF Certified GMP-PQS lead auditor
- Role
- Manager-corporate Qa Audits Asia at Procter & Gamble
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Rohit Purake
NSF certified GMP-PQS lead auditor with a history of working in the Pharma Industry. Audited several domestic and international facilities including the manufacturers of Active Pharmaceutical Ingredients (API), sterile and non-sterile finished dosage forms (FDF) products of various formulations, biological therapeutic products, re-packers, QC testing laboratories and dietary supplements manufacturer (21 CFR, Part Medical device 21 CFR, Part 820.Skilled in cGMP inspections, review of CMC documents, SOPs, batch records, deviations, Out of Specifications (OOS), change controls, complaints, recalls, CAPA, training, data integrity, quality agreements, equipment qualification, supply chain, external supplier qualification, internal audits, validations (process, cleaning and analytical method), sampling program, retention program and stability studies. Strong technical understanding of pharmaceutical processes, risk assessment, and regulatory requirements relating to pharmaceutical manufacturing, testing and distribution, GMP & GxP audits, Data integrity, 21 CFR Part 11, CSV, GAMP, Annex 11 and IT compliance etc.Working experience with Veeva, TrackWise, LIMS, Master control (e-QMS), e-DMS, MES e-BMR, SAP & ORACLE (QA modules)Previously Worked for STADA AG, Strides Pharma Science Ltd. Wockhardt Ltd. and Shalina Healthcare.
Experience
Manager-corporate Qa Audits Asia
Apr 2025 — Present · Mumbai, IN
Education
Laxmanrao Kirloskar Vidyamandir & Junior College,Palus
HSC Science
2006 — 2008
AMCP, Peth Vadgaon, Kolhapur
Master’s Degree, Masters of Pharmacy, Pharmaceutics
2013 — 2015
Bharati Vidyapeeth College of Pharmacy, Kolhapur
Bachlor of Pharmacy, Phamaceuticals
2008 — 2012
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