GMP Quality Specialist

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 based training including quality management principles and risk management practices.
• Supports the annual audit program by planning, leading, reporting and following up of internal audits, supporting external vendor assessments and providing back room assistance during hosted regulatory and client inspections
• Study Specific oversight for Pharmaceutical GMP Studies: Provides regulatory review of study related documentation (i.e. methods, protocols, reports, certificates of analysis, etc.)
• Support validation and verification activities, including but not limited to protocol development and execution and deviation / non-conformance resolution; review of key validation deliverables
• Contributes to continual improvement initiatives aimed at improving the efficiency / effectiveness of GMP operations both at site level and globally
• Reviews and approves site-based controlled documents (SOPs, Policies, etc.) to ensure compliance with applicable regulations, document management procedures and other relevant quality standards
• Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed.
• Other duties as assigned by management.

• Bachelor's Degree, e.g. Biology, Chemistry, Pharmacy, or relevant Engineering discipline
• 3 or more years of experience in GMP Quality Assurance role in an analytical testing or manufacturing environment.
• Experience with CAPA, change control, deviations, pharmaceutical QC testing methodologies and equipment validation procedures
• Fluency in English and Dutch

• Higher level qualification and/or equipment management /regulatory qualifications
• 2 or more years experience working in GMP compliant QC analytical laboratory environment
• 3 or more years of experience in GMP Quality Assurance role
• 2 or more years of experience in equipment validation and qualification

• Fluency in English and Dutch
• Understanding of applicable regulations and quality management systems / principles, tools, and standards.
• Detail oriented with knowledge of quality metrics and previous auditing experience preferred
• Good interpersonal / organizational skills, e.g. communication, decision making, problem solving, data analysis, negotiating, influencing
• Customer service oriented