Make your mark for patients
According to the Associate Director’s instructions, QA S&CI team organization and in cooperation with Braine Technical Operations (BTO) and related supporting services,
1. Assure that all technical operations related to the production & analysis of pharmaceutical products comply with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and UCB Corporate Policies & Procedures
2. (co-)develop and (co-)implement technically robust and compliant systems allowing to exploit, maintain, monitor and continuously improve operations
3. Develop and implement strategies that will assure the establishment and maintenance of a State of Compliance and a State of Control
4. Pro-actively identify, develop and implement quality improvements in response to business requirements, technical changes and regulatory requirements
5. Drive continuous improvement projects that will allow risk reduction, Improved Quality KPI and product quality
The position’s main focus is:
6. Quality Management System
7. Pest control management
8. Access management
9. Audit management (internal and external audits and inspections)
10. Continuous Improvement projects and activities
11. Backup-up functionThe position can act as back-up for his direct colleagues according to his manager’s instructions and after appropriate training
12. General QA RolePromote Quality and Operational Excellence and cultivate “Quality Culture”, “Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” across the UCB teamsDrive Quality Leadership on Quality & Compliance Strategy and interact with other functional areas to effectively communicate system & process requirementsAssure and maintain efficient UCB supplier’s evaluation process for equipment, consumables and services. Support QA Utilities/Facilities with system SQR preparation and reporting. Implement and maintain adequate Quality & Compliance Indicators and communicate results to appropriate levels of the organization.Driving quality leadership and technical expertise on Quality Management System compliance strategy and interacting with other functional areas to effectively communicate Quality Management System requirements through coaching and training.Maintaining and continuously improving the Quality Management System and related processes
13. audit management (internal and external audits & inspections).Leading or co-leading internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to GMP
14. Pest control:
15. Organizing and coordinating the GMP implementation of Pest control for the entire manufacturing siteManagement of Deviation, Investigation and CAPA related to pest control activities.
16. Access management
17. Support the facilities team for the access management (change control, deviations, ..) Support Inspection readiness program.As members of the inspection readiness team, participate to Audit & Inspection on site at UCB as SMEs, Front Officer and facilitator.
18. Continuous ImprovementDrive the identification of opportunities or improvementDevelop, drive and/or implement quality improvement and operational excellence projects in response to business requirements, observed issues, technical changes, identified risks, audit observations and changing regulatory requirementsLead or co-lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP
19. Eager to learn & grow in the position
20. High potential with affinity for Quality & Compliance and worldwide regulations pertaining to cGMP regulations pertaining to Pharmaceuticals & Medical Devices
21. Capability to work with minimal supervision
22. Ability to balance multiple priorities
23. Fact based decision maker with accountability
24. On-time delivering attitude
25. Team player with good interpersonal relationship and communication skills
26. Good oral and written communication skills
27. Capable of independently identifying problem situations and initiating problem solving
28. Ability to influence by persuasion
29. Stress resistant
30. Ability to make quality and compliance decisions in a business environment
31. Fluent in French and English are required
32. Ability to lead (small) projects teams and to motivate & inspire internal customers
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!