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Quality Pharma Specialist – Manufacturing Site Bulle
UCB · Bulle
Description du poste
About the role
UCB is seeking a Quality Pharma Specialist to join its Quality team at the Bulle manufacturing site. You will ensure product delivery complies with national and international regulations, GMP guidelines, and UCB quality policies.
Key responsibilities
- Provide end‑to‑end quality support for assigned products, managing deviations, OOS, CAPA, change control, complaints and equipment/utility qualification.
- Oversee process and cleaning validation, product quality reviews, continuous process verification and master data activation.
- Maintain relationships with internal and external stakeholders to ensure timely follow‑up of investigations, incidents and compliance actions.
- Lead or participate in internal audits and inspections according to the annual plan.
- Contribute to the drafting and approval of SOPs, methods, specifications and master batch records.
- Perform batch record review and release/reject activities as delegated.
Required profile
- Master’s degree in Life Sciences or equivalent experience.
- 3–5 years of experience in manufacturing, laboratory, QA/QC or regulatory affairs within the pharmaceutical sector.
- Proven ability to coordinate complex projects, meet critical deadlines and work autonomously under shifting priorities.
- Strong communication skills in both French and English, with the ability to interact with culturally diverse teams.
Required skills
- GxP/GMP compliance knowledge.
- Experience with deviation, OOS, CAPA, change control and complaint handling.
- Equipment qualification, process and cleaning validation expertise.
- Product Quality Review, Continuous Process Verification, master data activation.
- Batch record review and release procedures.
- SOP and technical document authoring.
- Fluency in French and English.
What we offer
- Opportunity to contribute to patient‑focused pharmaceutical products.
- Collaborative environment within a global biopharmaceutical leader.
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