Nitin Ahirrao
Associate Director, Quality |CQI & IRCA ISO9001 QMS Lead Auditorl LSS Black Belt l Contamination ControlsISterile Operations | Sterility Assurance | Supplier QualityI Data IntegrityIFDA InspectionReadiness& Remediation|
- Role
- Deputy General Manager at Apotex Inc.
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Nitin Ahirrao
Result oriented Pharmaceutical Quality Professional with more than 19 years of diversified experience in Audit & compliance, Quality management systems, Supplier Quality management, Validation & Qualifications, Product certifications, Distribution quality, Development Quality Assurance etc.•Certified Lead Auditor for GxP audits (GMP, GLP, GDP): Performed more than 250 audits (Domestic & International) for Sterile & Non-sterile Finished dosage forms, Biologicals & Vaccines, APIs, Excipients, External laboratories, Warehousing & Logistic services, Medical devices, GCP vendors. Lead investigator for product complaints and product failure.QMS implementationInvolved in many successful USFDA, MHRA, ANVISA, WHO, TGA, TFDA, audits. Expertise in Handling QMS (CAPA, Market Complaint, Deviation, Investigation and change Control)
Experience
Deputy General Manager
Dec 2024 — Present
Education
A.R.A. COLLEGE OF PHARMACY, DHULE.
Bachelor of Pharmacy - BPharm
2001 — 2005
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