Sudeep Ankush
Global Pharmaceutical Quality Compliance GCP/GMP Auditor Certified ISO 13485 Lead Auditor Medical Device at Abbott Healthcare Pvt.Ltd.
- Role
- Global Quality Compliance Auditor at Abbott
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Sudeep Ankush
Sr. Manager (Global Quality Audit & Compliance) with 18+ years of experience encompassing…
Experience
Global Quality Compliance Auditor
Mar 2020 — Present · Mumbai, IN
Identify non-compliances to established procedures during third-party audits of manufacturing companies, suppliers, internal manufacturing units, and critical vendorsInitiate due diligence audits and evaluate respective sites based on identified risks, and formulate corrective action plansSupervise the RLS staff in aseptic manufacturing assurance and microbiology testing procedures complying with data integrity principles of ALCOA as mandated by USFDA guidelinesEnforce stringent review and analytical data accuracy and traceabilityCoordinate and facilitate FDA inspections for GLP and GMP readiness of EU, US & ROW sitesDeliver training sessions for personnel on achieving high standards in GMP and GLL activities
Education
Dr. Babasaheb Ambedkar Marathwada University, Aurangabad
Master of Science - MS
2005 — 2007
Dr. Babasaheb Ambedkar Marathwada University, Aurangabad
Bachelor of Science - BS
2002 — 2005
Skills
- Microsoft Excel
- Gmp
- Quality System Compliance
- Microsoft Office
- Pharmaceutical Industry
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