Shaheen Ansari
Quality Auditor ENDO || INTAS Biopharma ll MSN Ltd. ll CIPLA II LUPIN II FDA Approved Microbiologist II
- Role
- Enterprise Quality Auditor at Endo
- Location
- Nagpur, MH, IN
- LinkedIn followers
- 500 followers
About Shaheen Ansari
Experienced Quality professional with a strong background in Vendor Auditing, Quality…
Experience
Enterprise Quality Auditor
Apr 2024 — Present
Responsible to perform audits globally for vendors [Sterile API, Packaging (Sterile / Non-Sterile), Excipients & Sterile Consumables], Microbiology laboratory and service provider as a part of vendor qualification program.*Responsible to perform audits of external CMO (Contract Manufacturing Organization) for sterile manufacturing.*Responsible for ensuring GMP compliance at site by executing corporate audits of Endo Sterile formulations sites as an SME for sterile operation.*Perform audit of Microbiological laboratory.*Support external CMO audits for sterile manufacturing products globally as per the current guideline requirement.*Ensure implementation of CAPA for the performed audit in timely manner.*To execute, review and follow-up for completion of technical agreement pertaining to supplier & service provider.*Maintaining the manufacturer/ supplier in SAP.*To support manufacturing site\'s as sterile SME during regulatory inspection.
Education
Seth kesarimal porwal college
Bsc
2010 — 2013
Rashtrasant Tukadoji Maharaj Nagpur University, Nagpur
Master of Science - MS
2013 — 2015
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