Sanket Shah
Quality Assurance GMP Auditor at Abbott
- Role
- Audit and Compliance - Qa Auditor (Latam) - Gmp Audit (Global) at Abbott
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Sanket Shah
Mr. Sanket Shah - 17+ years of experience in pharmaceutical regulatory environments with…
Experience
Audit and Compliance - Qa Auditor (Latam) - Gmp Audit (Global)
Apr 2022 — Present · Mumbai, IN
Global Quality LATAM region GMP Audit and compliance: GMP audit – Periodic audit, Follow-up audit, Due diligence audit, For cause audit, QQ assessment, and Quality agreement.• As role of lead auditor and Co-auditor, perform GMP quality system audit of Third-party manufacturer and supplier (Drug Product, Drug substance, TPL, Commodities, CDMO) with scope of Sterile / injectable, OSD, Topical, API and excipients, Sterile medical device, packing material, Contract laboratories and manufacturing.• 85 Audits (83 - Lead auditor, 02- Coauditor) involvement globally – India, APAC, Schengen (EU) and METAP region. • Audit preparation, audit execution, Audit report preparation, Compliance review and audit certification.• Auditor certification, Coordination with TPA auditors, qualification, and certification.• Improvement area identification, Regulatory knowledge management, skill development, and competency improvement.
Education
Jai Hind
Bachelor’s Degree
2002 — 2005
North Maharashtra University
Bachleors in Science
2002 — 2005
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