Make your mark for patients
We are looking for a QA Officer Dry Forms who is a team player and customer oriented to join our Pharma & Injectable Quality department, based in Braine-l’Alleud, Belgium.
About the role:
You will work closely with management to ensure the implementation and maintenance of an effective Quality Management System at the UCB Braine Site. Your responsibilities will include ensuring that local technical operations for manufacturing dry form pharmaceutical products (DP) comply with national and international regulations and guidelines (GMP) as well as UCB Quality Policies. You will also guarantee that marketed dry form pharmaceutical products are manufactured and supplied according to company Quality Standards.
What you’ll do
Under the responsibility of the Head of QA Dry Forms and in close collaboration with the Pharma Drug Product Dry Forms Manufacturing department, you will:
1. Participate in continuous improvement and product life cycle management, including technology transfer, process validation, equipment qualification, cleaning validation, stability studies, and filing submission preparation.
2. Review and approve change controls, failure investigations, deviations, CAPAs, and action plans, as well as master batch records and specifications.
3. Author and follow up on Product Quality Reviews, relevant SOPs, and Plant/Site Master Files.
4. Support the preparation, execution, and follow-up of internal and external audits and inspections.
5. Handle QA aspects with external customers and partners.
6. Assist the Manager in achieving team objectives and act as a backup for other QA Officers and Assistants as needed.
Interested? For this role we’re looking for the following education, experience, and skills:
7. Master’s degree in a scientific discipline.
8. At least two years of experience in Quality Assurance within a regulated pharmaceutical environment.
9. Proven expertise in meeting GMP standards
10. Fluent in both French and English, with strong written and verbal skills.
11. Proven decision-making capabilities, coupled with accountability and a results-driven approach
12. Skilled in establishing and maintaining positive relationships through diplomatic communication
13. Proven ability to contribute effectively within a team environment
14. Performs efficiently and reliably in high-pressure situations
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!