Make your mark for patients
We are looking for a Biologics Supply Officer (Specification and change notification coordinator) who is organized, systematic, and communicative to join our BGCMS (Bio & Clinical Manufacturing Sciences) team, based in our office in Braine l’Alleud, Belgium.
About the Role
As part of the Supply and Logistics team, you will play a crucial role in ensuring the smooth flow of materials to support both GMP. Your primary responsibility will be managing specifications, associated documents, and change notifications for materials required in biological and gene therapy production.
Who You'll Work With
You'll collaborate closely with laboratories, process engineers, and compliance teams, ensuring seamless coordination and communication across various stakeholders.
What You'll Do
1. Create and update specifications, sampling sheets, and associated documents in collaboration with laboratories and process engineers.
2. Evaluate/document Pharmacopoeia Change Notifications impacting products used, and implement necessary actions.
3. Manage supplier change notification evaluations for raw materials and define associated actions in collaboration with compliance.
4. Guide or contribute to continuous improvement projects.
5. Actively participate in deviation management systems (PR opening, investigations, CAPA, Change control, etc.), ensuring timely completion.
6. Supply and logistics management of GMP-required garments and tracking of associated suppliers.
7. Participate in safety activities.
Interested? For this role, we're looking for the following education, experience, and skills:
8. Bachelor's Degree
9. Experience in a regulated pharmaceutical environment (quality and/or production), including biotechnology, with a strong understanding of quality in a GMP-related setting
10. Experience with deviation, change control, and investigation methodologies
11. Excellent communication skills for effective collaboration with various teams/stakeholders
12. Continuous improvement mindset
13. Proficiency in French and good English skills
If you're passionate about Supply, thrive in a collaborative environment, and are eager to make an impact in the pharmaceutical industry, we want to hear from you! Apply now to join our dynamic team and contribute to the future of healthcare.
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!