Make your mark for patients
To strengthen our Global Analytical Operations department, we are looking for a talented individual to fill the position of: Senior QC Support Scientist - Critical Material Specialist in Braine l’Alleud .
About the role
Scope
1. Manage critical material supplies for analytical laboratories handling NBE, and/or GT from phase III to the end of the product life cycle
Nature
2. Offer expertise on UCB product regulations and provide support for critical materials in NBE and/or GT analytical labs (e.g., reference standards, control samples)
3. Facilitate efficient collaboration with QC, development labs, global analytical services, manufacturing, supply chains, QA, CLO, and CMO as needed.
What you will do
4. Provide expertise in NBE and/or GT critical materials for UCB products, regulations, and processes
5. Establish or revise critical materials specifications and related documents
6. Evaluate stability and determine expiry of critical materials
7. Interface with QC, development labs, Corporate analytical services, manufacturing, supply chains, Global Regulatory affairs, CLO, etc.
8. Define and implement global-level complex change control
9. Supervise or support climatic chambers, sample storage and flow
10. Serve as key user for LIMS std and reagents
11. Contribute to audit preparation and follow-up
12. Follow up on deviations and conduct root cause analysis
13. Participate in implementing a safe working environment to meet site safety objectives
Interested? For this position you’ll need the following education, experience and skills
14. Master’s Degree
15. Expertise in GMP, NBE and GT analytical knowledge and Critical materials regulation.
16. Validate decisions using strong analytical, troubleshooting and problem-solving skills
17. Manage multiple projects simultaneously
18. Team-oriented with a transversal approach
19. Stress-resistant
20. Fluent in French with a good level of English.
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!