Description
Site Conformance ManagerOur global pharmaceutical client is looking for 2 consultants to support the deployment of their compliance project on Belgium sites.
The compliance project has been established to ensure that all products are manufactured and released in compliance with registered details.
Key Responsibilities
• Coordinate the internal review of the CMC dossier.
• Supporting the deployment of the compliance project within Belgium operations including process revision / sop identification-writing-revision-harmonisation and training
• Coordinate the implementation of Process improvements across Belgian sites.
Profile
• University degree in Sciences or relevant extensive experience in Pharmaceutical industry.
• Biotech experience preferable
• Experience in regulatory affairs in registration dossier and regulation lifecycle variations mandatory.
• Technical knowledge of manufacturing or analytical practices are beneficial
• Excellent communication - ability to produce and deliver presentations as well as stakeholder management.
• Effective time management abilities.
• French or English language ability