Senior Quality Assurance Specialist – Pharmaceuticals
OLM Consultants · Luxembourg
Job description
About the role
Join a leading international pharmaceutical company as a Senior Quality Assurance Specialist. Based in Luxembourg, you will ensure that medicines meet the highest international quality standards throughout their lifecycle, working in a GDP and GMP‑regulated environment.
Key responsibilities
- Act as Responsible Person (GDP) for one Luxembourg entity and Deputy Responsible Person for another.
- Own and drive core Quality Management System activities across multiple pharmaceutical entities.
- Manage quality documentation, CAPAs, deviations, investigations, change controls, complaints, technical agreements and inspection readiness.
- Participate in supplier qualification, audits and continuous improvement projects.
- Collaborate with Quality, Regulatory Affairs, Supply Chain and Manufacturing teams to ensure regulatory compliance.
Required profile
- Pharmacist qualification obtained in an EU Member State, eligible for recognition in Luxembourg under Directive 2005/36/EC.
- 8–15 years of Quality Assurance experience in recognized pharmaceutical companies operating under EU GDP and/or EU GMP regulations.
- Fluent English (written and spoken) and professional proficiency (minimum B2) in French or German.
- Legal right to work in Luxembourg or eligibility to obtain a work permit.
Required skills
- Pharmaceutical Quality Management Systems
- Quality Agreements
- CAPA (Corrective and Preventive Actions)
- Deviation and Change Control management
- Audit planning and execution
- Supplier oversight and qualification
- Inspection readiness
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Published 1 month ago
Expires 3 days from now
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OLM Consultants
Luxembourg
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