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GMDP-0082

Senior Quality Assurance Professional

Disponible

Années d'expérience

Quality Assurance

Spécialisation

Pays-Bas

Localisation

À propos de cet expert

Results-driven Senior Quality Assurance professional with 20+ years of pharmaceutical experience, including 10+ years in GMP Quality Assurance across biologics, plasma-derived medicinal products, and Advanced Therapy Medicinal Products (ATMPs). Extensive experience in Change Control, Quality Systems Management, Deviatons, CAPA, Investigations, Supplier Quality, Regulatory Compliance, and Inspection Readiness. Recognized for providing independent quality oversight, driving contnuous improvement initiatives, and ensuring compliance with global GMP requirements while safeguarding product quality, patient safety, and data integrity.

Compétences

Expert

ATMP Change Control CAPA Management

Avancé

Biologics & biosimilars Plasma-derived medicinal products GDP Compliance GMP Auditing Internal auditing Supplier Auditing SOP Writing & Review Regulatory inspection support Data Integrity Sterile manufacturing Batch Release

Intermédiaire

Annual Product Quality Review SOP Writing & Review Process validation Controlled substances / narcotics Deviation Management

Certifications

Quality Risk Management Bootcamp Investigations Skills Program (ISP) NC/NC CAPA Training Batch Release Module Implementation Qualified Auditor Program Deviations and Investigations Program Quality Review Reports in TrackWise QMS ISO 9001 - Quality Management Systems Internal Auditor Training Course Yearly GMP Courses

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