Gunjan Vanarase

Director of Compliance (Corporate Quality) @Amneal Pharmaceuticals

Oak Ridge, NJ, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Aug 2017 — Present

Director of Compliance (Corporate Quality) @Amneal Pharmaceuticals

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New York, NY, US

EDUCATION

2013 — 2016

Temple University

Master of Science (MS), Quality Assurance and Regulatory Affairs

N/A

Shivaji University

BS Microbiology

SKILLS

DeviationsStandard Operating Procedure (Sop)Change ControlRegulatory SubmissionsLeadershipQuality AssuranceCapaGxpQuality AuditingAseptic ProcessingTeam BuildingComputer System ValidationPharmaceuticsFda GmpLimsRegulatory RequirementsGlpUspPharmaceutical IndustrySopFdaTrackwiseQuality SystemV&VCgmp PracticesDissolutionCleaning ValidationHplcHuman Resources21 Cfr Part 11ValidationQuality ControlGmpTechnology TransferRegulatory Affairs

ABOUT GUNJAN VANARASE

Experienced professional with a demonstrated history of working in the pharmaceutical and biological industry. Skilled in GMP, GLP, GCP, QMS, R&D QA, Supplier/CMO Quality, Clinical QA, Commercial Operations QA. Conversant with FDA, EU, HPFBI, WHO regulatory and quality requirements. Strong Quality Compliance leader with a Master of Science (MS) focused in Quality Assurance and Regulatory Affairs.

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Gunjan Vanarase — Director of Compliance (Corporate Quality) at Amneal Pharmaceuticals in Oak Ridge, NJ, US | Unifers