Make your mark for patients
We are looking for a CQV Quality Assurance Specialist who is detail-oriented, collaborative, and agile to join our Bio Drug Substance Quality – BE team, based at our UCB campus located in Braine-l'Alleud, Belgium.
About the role
You will play a key role in ensuring quality assurance across verification and validation activities for our new biological drug substance facility. Your work will directly support the reliable supply of drug substances and uphold compliance with internal and regulatory standards.
Who you will work with
You’re going to collaborate closely with the Quality Validation Manager and cross-functional teams including Bio Process Engineering, Validation, Maintenance, Metrology, and QA CSV specialists. You’ll be part of a dynamic environment adapting to the evolving needs of a new manufacturing plant.
What you will do
1. You will support projects as a Quality SME for design, qualification, and validation of utilities, equipment, and processes.
2. You will be responsible for reviewing and approving validation documentation in line with GMP standards.
3. You will manage deviations, CAPAs, and change controls related to CQV scope.
4. You will guide teams on GMP compliance and validation best practices.
5. You will ensure validated status is maintained through timely requalification and periodic reviews.
6. You will assist in audits and inspections, escalating critical issues as needed.
Interested? For this role, we are looking for the following education, experience, and skills:
7. You hold a Bachelor’s or Master’s degree in a relevant scientific field.
8. You bring at least 3 years of experience in the pharmaceutical industry.
9. You have hands-on experience in validation and quality assurance.
10. You are fluent in both French and English.
11. You are proficient with MS Office and Veeva Vault.
12. You thrive in dynamic environments and demonstrate resilience under pressure.
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!