GMP Quality Specialist

BVB Labcorp BV

📍 Mechelen, Flanders, Belgium

Full time Business Operations Specialists

Job Description

Labcorp is looking for an onsite GMP QA Specialist for our new CMC facility in Mechelen, Belgium.

Job Responsibilities:

  • Participation in projects to ensure facilities, utilities, equipment and computer systems are appropriately validated & qualified, including review and approval of key validation deliverables.
  • Review of metrology methods and specifications for accuracy / relevance and compliance with appropriate quality standards
  • Participates in and approves Quality Related Issue Resolutions, Corrective / Preventive Actions (CAPA), Change Controls, Vendor Management and Complaint Handling, Continual Improvement, as appropriate. Facilitation of root cause investigations / risk assessments and engineering solutions to address process quality issues
  • The review and approval of pharmaceutical GMP studies: Providing regulatory review of study related documentation (e.g. methods, protocols, reports, certificates of analysis, etc.).
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