GMDP-0033
GCP QA Specialist / Senior Quality Assurance Director
Disponible
20
Années d'expérience
Quality Assurance
Spécialisation
Suisse
Localisation
À propos de cet expert
GCP QA strategic expert with 20+ years in clinical quality assurance across Phase I-III trials. Expert in CRO oversight, deviation management, CAPA closure, audit lifecycle, inspection readiness, and GCP procedure development.
Compétences
Expert
SOP Writing & Review
Deviation Management
CAPA Management
Avancé
Supplier Auditing
GMP Auditing
GDP Compliance
Change Control
Regulatory inspection support
Internal auditing
Basique
Pharmacovigilance
Certifications
European Compliance Academy
Lean Six Sigma
Advanced GCP & Quality Risk Management
Leadership & Organizational Change Management
Demander des informations
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