Saumya Jena
Senior Manager QA, International Affiliates- Amgen
- Role
- Senior Manager Qa, International Affiliates- Amgen at Amgen
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Saumya Jena
Result-oriented and high performing Quality Assurance professional, having 21+ years of industry experience in pharmaceutical space in both Manufacturing Quality, Distribution Quality, Supply security and GMP Audit. Currentlyassociate with Amgen as an International and Distribution Quality Manager.Expertly on GMP and Supply Security Audit (certified DDA Auditor), Qualification of Stockist and CFA as per CDSCO norms, warehouse Qualification. Experience in Data integrity investigation and Data lifecycle process mapping, End to End Quality Storage / Distribution Operation on Cold chain products including Warehouse Qualification, Cold room qualification, Lan assessment etc, Customer Complaint investigation, Deviation investigation, Training, Change Control management, Quality Risk Assessment, End-to-end In-process Quality Assurance, Batch release, Self-inspection, Management escalation and FAR, Authority inspection management, Site remediation and culture change project.
Experience
Senior Manager Qa, International Affiliates- Amgen
Apr 2025 — Present · Hyderabad, IN
Responsible for IDQ (International and Distribution Quality) and GDQ (Global Distribution Quality)
Education
Biju Patnaik University of Technology (BPUT), Rourkela
B.Pharmacy
2001 — 2005
NIBM Institute
MBA, Logistics, Materials, and Supply Chain Management
2009 — 2011
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