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GMDP-0025

Senior Quality Assurance Specialist

Verfügbar
12
Jahre Erfahrung
Quality Assurance
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
Informationen anfordern

Interessiert an diesem Experten? Füllen Sie das Formular unten aus, um den Prozess zu starten. For €50, you'll receive a detailed anonymized CV. If you'd like to proceed to a personal introduction, that's €1000.