Make your mark for patients
To strengthen our Pharma and Injectable Quality department we are looking for a talented profile to fill the position of: QA Packaging and Medical Devices Officer – Braine l’Alleud, Belgium
About the role
This role ensures that local technical operations related to the packaging of pharmaceutical drug products comply with all applicable national and international regulations and guidelines (GMP) as well as company Quality Policies. You will guarantee that the finished marketed products are manufactured and supplied in accordance with the company’s Quality Standards, while proactively supporting operations to identify, develop, and implement quality and operational excellence improvements in response to business needs, technical changes, and evolving regulatory requirements.
You will work with
In this role, you will work closely with the Head of QA Packaging to achieve team objectives and support both quality assurance and business projects. You will collaborate with internal customers across the Braine Internal Manufacturing site. Additionally, you will interact with UCB management, providing technical expertise and guidance on quality assurance matters, regulatory CMC files, and company policies.
What you will do
1. Ensure QA team operations follow UCB quality systems and GMP, working with Head of QA Packaging
2. Manage relationships with internal customers to ensure timely follow-up on deviations, change controls, investigations, and CAPA activities.
3. Actively support process simplification and streamlining to eliminate unnecessary obstacles and foster ongoing quality improvement, including procedure reviews.
4. Offer technical expertise based on experience, provide interpretation and guidance to UCB management regarding Quality Assurance matters, regulatory CMC documentation, and applicable UCB Policies.
5. Review and authorize RA documents within the documentation system when this is required.
6. Follow-up of product related:
7. Change control (temporary or permanent)
8. Deviations / investigations/ OOS
9. CAPA
10. Examine and approve Packaging SOPs
11. Assess and authorize validation documents
12. Prepare Line Quality Reviews and monitor their progress
13. Work together with the Head of QA Packaging to reach team goals and assist with QA and business initiatives
14. Provide assistance during audits (internal, supplier, partner) and inspections
Interested? For this position you’ll need the following education, experience and skills
15. Master’s degree or academic background in a relevant scientific field
16. Fluent French and English communication (oral and written)
17. Minimum of two years' experience in a quality assurance position
18. Proven ability to make decisions based on facts, demonstrate accountability, and deliver results
19. Knowledge of global regulations related to GMP
20. Excellent at building relationships with others
21. High level of discretion and ethical standards
22. Demonstrated aptitude for effective teamwork
23. Able to perform effectively 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!