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.

Minimum Qualifications:

• Bachelors 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

Preferred Qualifications:

• 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

Additional Job Standards:

• 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

Labcorp is expanding its global BioPharmaceutical Chemistry Manufacturing and Control (CMC) footprint and is opening a new CMC facility in Mechelen Belgium.

Biopharmaceutical CMC provides independent objective GMP analytical testing for manufactured medicinal products from late discovery through post-market approval on behalf of global clients. With a strong portfolio of clients and over 25 years of expertise the BioCMC team provides advanced characterization method development stability and routine QC release for biologics vaccines ATMPs and a breadth of other complex biomolecules.

With this new laboratory in Belgium we aim to offer a more comprehensive solution and accelerate the availability of new products for patients. The new site has been strategically developed to complement our existing capabilities in York and Harrogate (UK) and Greenfield (US) and introduce a new CMC analytical testing solution for commercial drug products in the European Union (EU).

This expansion is a key milestone in our long-term plan to strengthen support for pharmaceutical and biotechnology partners who rely on Labcorp for complex CMC and regulatory testing services. If you would like to join us and be a part of this exciting journey take a look at the fantastic opportunities we have to offer.

Were looking for a handson GMP Quality Specialist to establish and drive the quality operations for our new Mechelen facility.

Daytoday you will review data reports and quality-related documentation to ensure full regulatory compliance including managing quality issues CAPA and change controls. From a QA perspective you will be responsible for reviewing QMS documentation such as deviations CAPAs and work instructions. You will also oversee equipment-related documentation including validation activities (IQ/OQ/PQ) from initial qualification through to implementation and retirement. Once equipment is operational you will continue to review calibration records issue-related documentation and ensure systems remain appropriately validated and compliant.

In the first months youll be heavily involved in equipment set-up documentation new SOPs writing.

This is a unique opportunity to shape a new site solve problems and lead local operations within a global quality framework.

Labcorp is proud to be an Equal Opportunity Employer:

Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race religion color national origin sex (including pregnancy childbirth or related medical conditions) family or parental status marital civil union or domestic partnership status sexual orientation gender identity gender expression personal appearance age veteran status disability genetic information or any other legally protected characteristic. Additionally all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.

We encourage all to apply

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