GMDP-0043
Senior QA Consultant / Validation Specialist
Disponible
11
Années d'expérience
Validation / Qualification
Spécialisation
Suède
Localisation
À propos de cet expert
Senior QA/Validation Consultant with 10+ years in pharma and medical devices. Expert in cleanroom compliance, CAPA, change control, product release, non-conformance, and GMP/ISO standards including ISO 13485, ISO 14644, EN 17141.
Compétences
Expert
CAPA Management
Deviation Management
Change Control
Avancé
Out-of-Specification (OOS) Investigation
IQ/OQ/PQ Validation
Equipment qualification
Process validation
SOP Writing & Review
Facility qualification
Batch Release
Annual Product Quality Review
Medical devices & combination products
Intermédiaire
Computer system validation
Internal auditing
Stability Study Design & Execution
Supplier Auditing
Certifications
Validering och kvalificering
Demander des informations
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