Nick Fava

Assoc Director, Gmp Quality Assurance, Api @Esperion

Detroit, MI, US

EMAILS

[email protected]

MOBILE NUMBERS

+91 *********19

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WORK HISTORY

Nov 2019 — Present

Assoc Director, Gmp Quality Assurance, Api @Esperion

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Ann Arbor, US

Lead and managed five Active Pharmaceutical Ingredient (API) GMP commercial suppliers, which included change controls, deviations, OOS investigations, root cause analysis, corrective actions and preventive actions (CAPAs), and complaints-Conduct quality reviews of API for Investigational Drug Product (i.e, Clinical Trial Materials) and Commercial Drug Product quality records and reports, including but not limited to batch records, quality control specifications, analytical method validation protocols and reports, stability protocols and reports-Establish and maintain quality oversight of API suppliers including performing supplier qualifications, establishing/monitoring compliance to Quality Agreements, and utilizing quality metrics to track vendor performance.

EDUCATION

N/A

Oakland Community College

Assoc in Science

N/A

Michigan State University

SKILLS

Change ControlEquipment QualificationQuality Auditing21 Cfr Part 11ValidationCommissioningCorrective and Preventive Action (Capa)U.s. Food and Drug Administration (Fda)ManufacturingWarehousingQuality AssuranceVerification and Validation (V&V)Computer System ValidationAuditingQuality SystemV&VProject ManagementU.s. Title 21 Cfr Part 11 RegulationQuality ControlGmpStandard Operating Procedure (Sop)Sop DevelopmentPharmaceutical IndustrySopFdaSoftware DocumentationRoot Cause AnalysisCapaCross-Functional Team LeadershipFacility Start-Up

ABOUT NICK FAVA

Results driven quality professional with progressive pharmaceutical experience dealing…

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