La société Pharmadiem, spécialisée en management et ingénierie des grands projets recrute un Expert Spécialiste QA System confirmé pour le compte d’un de ses clients en Belgique.
Vos missions :
1. Ensures Efficient Management and Execution of the Event & CAPA Process (GEMS). Ensures that events/CAPAs and associated investigations are appropriately and timely performed and documented. Ensure that reports are available. Supervise and support the activities related to Event & CAPA Process (GEMS – Trackwise 8) for the Site;
2. Effectiveness of Quality Systems deployment and execution is demonstrated through KPIs and management reviews are being conducted in line with Client Guidance. Define and manage the action plans to ensure KPI are satisfactory.
3. Participate to the Global Event Review Board.
4. Manage the MR of Quality Systems.
5. Manages the Quality Risk Management System.
6. Train employees on EVENT/CAPA system. Monitor the EVENT/CAPA system to ensure compliance to the Global procedures and Regulations and evaluate additional need for training/coaching of the users
Profil recherché :
7. Master degree in Chemistry/Biology/Quality/Agronomy/pharmaceutical sciences
8. Qualités requises :
9. Min 5 years’ experience in Quality or Manufacturing of biotech or pharmaceutical products.
10. Min 5 years’ experience in leading teams
11. Management and leadership skills
12. Sets clear Priorities, manages through KPIs
13. Excellent communication Skills with teams, peers, global partners
14. Good Organizational skills
15. Autonomous
16. Good English knowledge
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