Qualified Person QA Engineer - Remote Eligible, Mechelen

Labcorp; Antwerpen; Sur place; EUR 70 000 - 110 000; Plein temps

Avantages offerts par ce poste

Remote working

Career progression

Well-being programs

Résumé du poste

Labcorp in Mechelen, Belgium, seeks an onsite Quality Engineer - Qualified Person to join our new CMC facility. You will implement and maintain QMS, lead QA activities, and oversee validation and regulatory compliance across studies and release.

Fluency in English and Dutch is required; a Master in Pharmacy; and a Certified Qualified Person by FAMHP are expected. This is a global organization with strong development opportunities.

Qualifications

• Certified Qualified Person by FAMHP.
• Master degree in Pharmacy is required.
• 3+ years of quality-related work experience.

Responsabilités

• Supports the implementation of a quality management system that complies with domestic and international regulations. Ensures local compliance with the QMS requirements.
• Plays a leading role in the implementation of a quality management system that complies with domestic and international regulations. Ensures local compliance with the QMS requirements.
• Oversees, and approves Quality Related Issue Resolutions, Corrective / Preventive Actions (CAPA), Change Controls, Vendor Management, Complaint Handling, Continual Improvement and NCM/MRB systems, as appropriate. Engineers solutions to address product and process quality issues.
• Supervisory responsibility for a segment of the QA team providing workload assignment, recruitment, performance evaluation, professional and personal training and development, implementation and follow-up of site departmental objectives, etc. May deputize for the Site QA Lead.
• 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; assess and report post-market surveillance data in accordance with regulatory requirements.
• Promote awareness of the applicable regulations and associated quality management system and lead the development / delivery of regulatory based training including quality management principles and risk management practices.
• Supports the annual audit program by scheduling, planning, leading, reporting and following up of internal audits, leading/supporting external vendor assessments and hosting regulatory and client inspections
• Study Specific Oversight - Pharmaceutical GMP Studies: Provides regulatory approval and accountability for release (or rejection) of study related documentation (i.e. batch records, methods, protocols, reports, certificates of analysis, etc.) and/or pharmaceutical material/product for use in clinical trials.
• Represents QA on key projects to ensures facilities, utilities, equipment and computer systems are appropriately validated/qualified; approval of key validation deliverables
• Reviews and approves 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.
• Where needed provides QP confirmation statements for associated certificates of analysis
• Other duties as assigned by management.

Connaissances

Fluency in English and Dutch

Formation

Master's degree in Pharmacy

Bachelor's degree in life science

Description du poste

Labcorp in Mechelen, Belgium, seeks an onsite Quality Engineer - Qualified Person to join our new CMC facility. You will implement and maintain QMS, lead QA activities, and oversee validation and regulatory compliance across studies and release.

Fluency in English and Dutch is required; a Master in Pharmacy; and a Certified Qualified Person by FAMHP are expected. This is a global organization with strong development opportunities.