Make your mark for patients
We are looking for a QA Officer – Analytical Services who is proactive, analytical, and results-driven to join our team at Braine Quality Assurance in our Braine office, Belgium .
About the role
As a QA Officer Analytical Services, you will play a crucial role in ensuring the integrity and compliance of laboratory operations. You will work closely with various teams to develop and implement strategies for maintaining compliance with regulations and corporate policies. Your focus will be on ensuring quality oversight of laboratory operations (deviations, change control, OOS/OOT investigations, etc.), developing/implementing/optimizing laboratory processes, driving continuous improvement, and fostering a culture of operational excellence.
Who you'll work with
You'll collaborate with a dynamic team of professionals dedicated to maintaining the highest standards of quality and compliance. Together, we strive to exceed expectations and drive excellence in everything we do.
What you'll do
1. Ensure quality oversight of laboratory operations:Oversee all aspects of laboratory operations to ensure they adhere to internal procedures, policies, and applicable regulations.Ensure effective follow-up of deviations, investigations (e.g. OOS, OOE), change control, qualification/validation of laboratory equipment/systems and laboratory documentation.Conduct regular inspections and audits to identify areas for improvement and ensure compliance.Participate in the preparation for health authority’s inspections and be an active member during audits & inspections.
2. Develop and implement strategies for maintaining compliance with regulations:Stay updated on relevant regulations and guidelines (EMEA, FDA, PIC/S, ICH) and ensure all systems and processes comply.Proactively identify areas of non-compliance and develop strategies to address them effectively.Implement & maintain quality metrics as well as quality reviews driving the identification of opportunities for improvement.
3. Drive continuous improvement initiatives:Lead or participate in projects aimed at improving quality control systems and processes.Collaborate with cross-functional teams to implement best practices and innovative solutions.Analyze current processes and systems to identify inefficiencies and areas for optimization.Implement changes and improvements to enhance quality with efficiency.
4. Support interactions between UCB and external laboratories:Serve as a liaison between internal UCB teams and external laboratories.Coordinate investigation and ensure seamless communication and collaboration.
Interested? For this role, we're looking for the following qualifications, experience, and skills:
5. Master's Degree
6. Strong knowledge and proven experience in analytical techniques mainly used in biological products testing (e.g. HPLC, Spectrophotometry, Elisa, Capillary Electrophoresis, Cell-based Assay, etc.) and applicable regulations
7. Experience with Quality Management Systems and auditing
8. Ability to balance multiple priorities and provide leadership
9. Excellent interpersonal and communication skills
10. Fact based decision maker with accountability and delivering attitude
11. Team player
12. Stress resistant
13. Fluent in French and English
If you're passionate about quality and compliance and thrive in a collaborative environment, we want to hear from you! Join us in our mission to drive excellence and make a difference in the world of pharmaceuticals. Apply now and let's shape the future of quality together.
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!