Freelancer Detail | GMDP.Expert

GMDP-0066

Quality Control / Quality Assurance Professional

Disponible

Années d'expérience

Quality Control

Spécialisation

Pays-Bas

Localisation

À propos de cet expert

QC/QA professional with 6 years in cGMP-regulated pharma and biologics. Specialises in deviation management, root cause analysis, CAPA, OOS investigations, microbiological testing, and regulatory compliance.

Compétences

Avancé

Out-of-Specification (OOS) Investigation Analytical testing Microbiological testing Biological & Immunological Testing Data Integrity SOP Writing & Review CAPA Management Deviation Management

Intermédiaire

Batch Release Internal auditing GMP Auditing Method validation Sterile manufacturing Process validation Regulatory inspection support Biologics & biosimilars

Certifications

Chemical and Biological Spill Compendial HPLC Practices Training in laboratory equipment calibration, OOS investigations, Method Validation Good Clinical Practice Sterility Test and Rapid Microbiological Method for Pharmaceuticals

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