CAPA Process Manager - Quality Engineer

Calling all cGMP and CAPA specialists, one of our leading multi-national biomanufacturers specializing in packing is looking for an experienced Quality Engineer to start with them ASAP. If you currently have extensive experience in cGMP and looking to start work ASAP this IS the role for you.

A CAPA Process Manager will be responsible for the standardized company regulation ensuring the requirements are met and maintained in compliance with CAPA processes. They will work in cohesion with different teams and departments ensuring that processes and procedures are efficiently maintained.

A typical day will revolve around the following:

• Following changes in legal and quality Standards requirements and user needs in order to maintain a compliant and efficient CAPA process
• Follow up on KPIs, draw up charters, dashboards, risk registers, monitor the performance of the CAPA process and adjust where necessary
• Coordinating periodic review and keeping up to date all procedures and training material linked to the Process, providing training
• Coaching users of the CAPA process
• Ensure continuous improvement of the CAPA process
• Point of contact for the CAPA process during audits and inspections
• Know and monitor the links with other related processes and Process Owners
• Report ongoing activities to Steering Teams/Management review
• Building expertise in using Trackwise (software) to manage CAPAs
• Implementing a new software Veeva Vault (will be part of the activities in the coming months)
• Benchmarking both inside and outside Puurs

A sucessful candidate will have the following knowledge and skills:

• Good coaching capacities (inspire, motivate, support, …), strong in indirect leadership
• Strong communicator and able to motivate and inspire colleagues at different levels (negotiating, assertive, persuasive, diplomatic, …)
• Strong in Process/conceptual/analytical thinking and driven to find pragmatic solutions and achieve results
• planned
• Team player
• Good knowledge and understanding of the cGMPs, knowledge of medical device legislation is a plus
• Experience with CAPA is a must, experience with Trackwise is a plus, experience with Veeva Vault is a plus

Languages:

Dutch and English

If you would like to find out some more information and be put forward for this role please do apply below, I will be more than happy to organise a call with you! Looking forward to your application.