BeerseIFarmaceutische industrie


Business Description: 
The Clinical Supply Chain (CSC) organization is responsible for the end-to-end supply chain management of clinical supplies aligned with the needs of each therapeutic area. The Clinical Supply Integrator (CSI) acts as project leader, leading the CSC subteam responsible for successfully delivering supply strategies matching the clinical program. The Clinical Supply Integration Coordinator will support and work closely with the CSI team. This includes but is not limited to managing CSI owned Change Controls and Quality Investigations, coordination of 3rd party product requests and providing support in timely completion of CSI deliverables. 
Responsibilities of the Role: 
• Management of CSI owned Change Controls and Quality Investigations 
• Once trained, fully manage all records from initiation up to completion in the appropriate system 
• Attend weekly quality meetings to provide updates on CSI owned records 
• Follow-up with CSI team as needed to ensure timely completion of records 
• Coordination of 3rd part product requests 
• Obtain required input and manage requests through Sharepoint 
• Follow-up with expert team to ensure timely delivery of stability statement 
• Create Material Introduction Checklist and follow-up through approval in appropriate system 
• Provide support in timely completion of CSI deliverables 
• Document management, periodic reviews, system support, metrics, … 


• A Bachelor’s Degree in Supply Chain or Engineering ( or equivalent with 1-3 years experience

• Prior experience working in a clinical or commercial supply chain is preferred 
• Knowledge of cGMP and Agency requirements (Regulatory requirements from Health Authorities) is preferred 
• Good written and oral communication skills in Dutch & English 
• Ability to collaborate internally and work in a matrix environment
• Ability to work in a multi-cultural environment 
• Ability to work effectively with different systems (Quality Event Tracking System (Trackwise), Document management system (changing now from Docspace to TruVault), vTMF Archiving system, Sharepoint ) 
• Results oriented

Organisatie- en afdelingomschrijving

Select Projects is part of the Select group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis. Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro) chemical, Construction and Rail. From our offices in Antwerp and Rotterdam we optimally support our experienced specialists so that they can deliver high quality to our customers at all times.


You get an attractive salary package with interesting fringe benefits. A company car, meal vouchers, group insurance and mobile phone subscription are possible. We ensure that you end up in a pleasant working environment with nice colleagues and opportunities to develop and further develop. Together with you, we map out a training course tailored to your future plans and needs.

Heb je nog vragen?
Aartje Huybrechts Human capital developer Select Projects +32 3 612 22 92
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