Our client is one of the global leader in healthcare and pharmaceutical products, with base in Leiden.The company focuses on the discovery, development, manufacture, and marketing of vaccines to protect people worldwide from infectious diseases.
As a GMP Expert you will be the first point of contact within production teams for questions related to cGMP (training, inspections, audits and documentation). You will also work on the maintenance and imrpovement of the current cGMP systems.
- First departmental contact for questions about cGMP systems
- Initiating and handling of compliance records (Change Control, nonconformances and CAPA records) including root cause analysis
- Supporting/leading in keeping process documentation up-to-date
- Coordinating training system within the department
- System ownership of general production processes like gowning, routing and flow, segregation
- Leading role in the inspection readiness of the department, execution of inspections and follow up
- Working accurately and detecting opportunities for improvement with proper follow up
- HBO/BSc with 3 years of proven experience in pharmaceutical/biotechnology
- Experience with change controls, non-conformances and CAPA records
- Experience with cGMP and EHSS standards is required
- Experience with documentation systems required (Truvault preferred)
For more information please contact Carla Garcia at firstname.lastname@example.org or +31 (0) 20 658 98 01.