Freelancer Detail | GMDP.Expert

GMDP-0043

Senior QA Consultant / Validation Specialist

Available

Years Experience

Validation / Qualification

Specialization

Sweden

Location

About This 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.

Competencies

Expert

CAPA Management Deviation Management Change Control

Advanced

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

Intermediate

Computer system validation Internal auditing Stability Study Design & Execution Supplier Auditing

Certifications

Validering och kvalificering

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