Se rendre au contenu
Aller au contenu principal

GMDP-0025

Senior Quality Assurance Specialist

Disponible
12
Années d'expérience
Quality Assurance
Spécialisation
États-Unis
Localisation
À propos de cet expert

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

Compétences

Expert
CAPA Management SOP Writing & Review Deviation Management
Avancé
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
Intermédiaire
Process validation Computer system validation Regulatory Submissions
Demander des informations

Intéressé par cet expert ? Remplissez le formulaire ci-dessous pour démarrer le processus. For €50, you'll receive a detailed anonymized CV. If you'd like to proceed to a personal introduction, that's €1000.