GMP Quality Specialist

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.). - Monitors, compiles and reports on appropriate quality metrics and data trends related to the local performance of the quality management system for input into the Management Review Process - Participate in the development / delivery of regulatory bas...