PHARMA - QA Coordinator/QP Delegate - Quality Assurance - Assurance Qualité

Opportunity to learn. Opportunity to grow your career. But most importantly, opportunity to improve the lives of hundreds of millions of people around the world. And with the combination of Shire and Baxalta, these opportunities just got better. Together we are the leading global biotechnology company focused on rare diseases and highly specialized conditions. With nearly 22,000 employees across more than 100 countries, our employees are making a difference around the world, all the while advancing their careers and giving back to the communities in which they live and work. If you are passionate about what you do, motivated to deliver results and inspired to make a difference in the world, we invite you to take the next step on your career journey with us.

Summary
Supervise and support the Receiving & Inspection (R&I) team & system for raw materials


Responsibilities:

•Supervise and support the Receiving & Inspection (R&I) system for raw materials
•Supervise the R&I activities and ensure the availability of the raw materials
•Manage the events and act as quality approver for events related to unreleased raw materials
•Owner of the Level 2 material quality system. Ensure adequate management of◦New L2 material implementation
◦L2 Supplier change notifications
◦L2 Non-conformity management / SCAR
◦L2 Specifications

•Act as an interfacility assessor for raw material changes
•Ensure the implementation of the local and global R&I procedures and specifications
•Participate actively to the continuous improvement projects related to R&I activities
•Define, review and analyze the R&I KPI
•Supervise the Receiving & Inspection team◦Develop team and follow the team’s objectives
◦Perform 1/1 and support team on daily basis
◦Manage resources
◦Ensure staff is adequately trained

•Act as a delegate QP for the release of raw materials and finished products

 
Profile
•University degree
•Demonstrated people management experience
•English : good spoken and written knowledge
•Knowledge of quality systems, EU and FDA regulations, cGMP, GDP, Eudralex, Annex 16
•QP: QP Registration Number (AFMPS-moniteur belge)
•Ability to drive a team to excellent results
•Ability to manage priorities / Stress-resistant
•Ability to work in a multi-disciplinary team environment
•Fact-based / Critical thinking / Rigor, autonomy and proactivity
•Advanced knowledge of Microsoft Office is a plus
•Knowledge of JDE is a plus

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SHIRE / Baxalta est un leader international du secteur biopharmaceutique spécialisé dans le développement, la fabrication et la commercialisation de thérapies pour les affections rares et chroniques en hématologie, oncologie et immunologie.

Lancée en 2015 après sa séparation de Baxter International, SHIRE / Baxalta hérite de décennies d'expérience dans le secteur biopharmaceutique. Les thérapies de Baxalta sont disponibles dans plus de 100 pays dans le monde et l'entreprise emploie plus de 16000 personnes dans le monde. SHIRE / Baxalta est une entreprise qui cherche des solutions pour le patient, en développant ses produits d'une part et en encourageant ses collaborateurs d'autres part, en encourageant les performances, la progression et l'inspiration.