F or the Quality Assurance Department of our Belgian site located in Braine-l’Alleud, we currently have an opening for an experienced Quality Operations Specialist - NPI.
The key tasks are :
Operations:
1. Organize, manage and participate in QA activities from early-phase API manufacturing to Process Validation and in Cleaning activities, including:Review and approval of the documentation linked to quality agreements, process optimization & validation, analytical, operations and cleaning documentation to comply with the cGMP or other legislation, with PolyPeptide Quality System and customer requirementsManagement and approval of change controls, CAPAs & deviations and participation in on-line problem solving with other departments
Release of API batches:
2. GMP and Quality
3. Work with counterparts from Strasbourg and other sites to establish common (best) practices in quality related systems, policies and procedures
4. Recommend changes in practices to enhance the conformance to GMP within all departments
5. Perform internal and external audits as required
6. Hygiene, Safety and Environment
7. In collaboration with safety department, ensure proper training of personnel in place in order to prevent risk of accident or failure during operations.
8. People management and team spirit
Experience in People Management
9. Plan and prioritize the activities of the direct reports to minimize the production disturbance, meet the planning objectives as well as the Quality and Regulatory expectations.
10. Ensure that the required and continuing training of the direct reports is carried out and adapted according to needs
11. Motivate, listen to and manage the direct reports, maintaining a sound work spirit and manage relationship problems
12. Implement "empowerment" and "full management" ways of life throughout the organization
13. Evaluate annually the direct reports
Information/Communication:
14. Be the point of contact for customers quality topics (audits, customers requests, complaints and recalls)
15. Inform management in case of any major quality or people management problem
16. Make personnel aware of the importance of safety, environmental and GMP issues
What we expect from you is :
17. Master in Sciences with minimum 5 year experience in QA in a GMP Environment & NPI
18. Fluency in French and English is mandatory (spoken and written English)
19. Excellent command of Word, Excel and PowerPoint
20. High organizational skills, good interpersonal skills, flexibility in tasks and schedules
21. Sense of responsibility, enthusiasm, diplomacy and team spirit