Functieomschrijving
For our client in Zwijnaarde, we are looking for a QC Analyst.
Your tasks and responsabilities include:
1. Responsible for the completion of QC testing related to the manufacturing of autologous products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
2. Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.
3. Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
4. Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
5. Perform peer review/approval of laboratory data.
6. Utilize electronic systems (LIMS) for execution and documentation of testing.
7. Create, review and approve relevant QC documents, SOP’s and WI’s.
8. Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
9. Other duties will be assigned, as necessary
Profiel
- Education:
You have you have a Bachelor's degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical industry.
Capabilities, Knowledge, and skills:
10. Experience in a Quality Control setting is preferred.
11. Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
12. Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
13. Knowledge of Good Tissue Practices is required.
14. Detailed knowledge of QC test methods and related equipment is preferred
15. Excellent written and oral communication skill are required
16. Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
17. Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
18. The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
19. Comfortable with speaking and interacting with inspectors.
Aanbod
20. You will join an exciting pharmaceutical company with opportunities for growth.
21. You will work within a strong and respectful diverse team where everyone is welcome.
22. Your Team is a diverse team who speaks Dutch or English
23. You will receive an attractive salary package including meal vouchers and eco vouchers.
24. Hospitalisation insurance, group insurance and bonus complete the salary package.
25. You will work in a 2-shift system (6 am - 4 pm / 2 pm - 00 am) in a regime in which you work 4 days, have 4 days off, etc. This gives you a nice balance between Work and Personal life
26. You will work in an environment where loyalty and team spirit