Freelancer Detail | GMDP.Expert

GMDP-0025

Senior Quality Assurance Specialist

Im Einsatz

Jahre Erfahrung

GMP & GDP

Spezialisierung

Vereinigte Staaten von Amerika

Standort

Über diesen Experten

Highly accomplished Quality Assurance Leader with over a decade of experience driving compliance, risk management, and continuous improvement across highly regulated laboratory, pharmaceutical, and clinical environments. Proven expert in directing global CAPA program strategies, executing complex root-cause analyses, and maintaining rigorous audit readiness for regulatory bodies. A collaborative leader adept at bridging cross-functional gaps between Clinical, Laboratory, and IT teams to safeguard data integrity and enhance systemic performance

Kompetenzen

Experte

CAPA Management SOP Writing & Review Deviation Management

Fortgeschritten

Batch Release Change Control Annual Product Quality Review Supplier Auditing Equipment qualification GMP Auditing Deviation Management Out-of-Specification (OOS) Investigation Regulatory inspection support Data Integrity Internal auditing

Mittelstufe

Process validation Computer system validation Regulatory Submissions

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