Make your mark for patients
We are looking for a CSV Quality Assurance Specialist who is detail-oriented, collaborative, and resilient to join our Bio drug substance Quality – BE team, based at our UCB campus located in Braine-l'Alleud, Wallonia, Belgium.
About the role
You’re going to play a key role in ensuring the quality and compliance of computerized systems in our new biological drug substance facility. You will help shape a reliable and efficient validation environment that supports our mission to deliver high-quality medicines.
Who you will work with
You will be part of the Quality Support Team, reporting to the Quality Validation Manager. You’ll collaborate closely with Bio Process Engineering, Validation, IT & Automation, and CQV QA specialists to ensure alignment and excellence in validation practices.
What you will do
1. You will support projects as a Quality SME for computerized system validation.
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 CSV scope.
4. You will guide stakeholders on GMP-compliant validation processes.
5. You will contribute and participate in audits, inspections, and continuous improvement initiatives.
For this role, we are looking for the following education, experience, and skills
6. You hold a Bachelor’s or Master’s degree in a relevant scientific or technical field.
7. You have at least 5 years of experience in the pharmaceutical industry.
8. You bring proven expertise in computerized system validation (CSV).
9. You are fluent in both French and English.
10. You are comfortable with tools like MS Office and Veeva Vault.
11. You demonstrate agility, stress resilience, and a collaborative mindset
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!