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GMP Quality Specialist

Company

BVB Labcorp BV

Location

Mechelen, Flanders

Type

Full time

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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