Make your mark for patients
To strengthen our QA Systems & Continuous Improvement department, we are looking for a talented profile to fill the position of: QA Systems Officer Utilities – Braine l’Alleud, Belgium
About the role
QA Systems Officer Utilities will ensure that all technical operations related to the production and analysis of pharmaceutical products comply with applicable regulations and guidelines (such as EMEA, FDA, PIC/S, ICH, and best practices defined by relevant organizations) as well as UCB Corporate Policies and Procedures, while also developing, implementing, and continuously improving robust and compliant systems and strategies that maintain and enhance operational and product quality in line with both regulatory and business requirements.
You will work with
You will be collaborating closely with the QA Systems & Continuous Improvement team, working in partnership with Braine Internal Manufacturing (BIM) and various supporting services. The role primarily involves providing support to Beltech Utilities operations and activities, which means regularly interacting with colleagues from manufacturing, quality assurance, technical services, and other departments involved in maintaining and improving the systems that support pharmaceutical production.
What you will do
General QA Role
1. Ensure compliance with all relevant regulatory requirements and UCB requirements
2. Organize adequate quality oversight on GMP documentation and activities
3. Promote leading and proactive management of deviations, corrective and preventative actions, and change controls.
4. Actively participate to the quality governance in place within the organization
5. Ensure escalation of significant/critical quality problems to the appropriate levels of management following the standards set by the UCB QMS.
6. Participate in the preparation for regulatory inspections, providing direct support to system owners and main customers during inspections.
7. Foster a culture of quality, compliance, and continuous improvement within the organization.
Beltech Utilities support
8. Together with BIM Teams, ensure direct follow-up of Compliance Audit activities, Deviations, Failure Investigations, Change Control, Qualification/Validation activities and associated documentation approval.
9. Drive the identification of opportunities for improvement, development and implementation of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations and regulatory requirements at the Braine site.
10. Lead or co-lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP.
11. QA follow-up of utilities/Beltech related projects and project management.
12. Act as back-up for your direct colleagues or for your manager when needed
Interested? For this position you’ll need the following education, experience and skills
13. Master's degree in a relevant field (e.g., Engineering, Science or a related discipline).
14. Fluency in French and a good level in English are required
15. Experience in a regulated pharmaceutical environment or other life science or health related field is mandatory
16. Experience with Quality Management Systems and Auditing is a great asset
17. Demonstrates outstanding writing proficiency and can compose clear, concise documentation.
18. Skilled at handling several priorities simultaneously
19. Demonstrates accountability by making decisions based on factual information
20. Demonstrates the ability to independently identify issues and proactively implement solutions
21. Collaborative team member with strong interpersonal and communication abilities
22. Skilled at communicating clearly and effectively both verbally and in writing
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!