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  • Location

    Leiden, Netherlands

  • Job title:

    GMP and Documentation specialist

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The Company 
This organisation is a world-leader in the research & development and production of biotechnology and pharmaceutical products. Their main focus is the production of biologic products and vaccines. 

Role Description 
As a GMP and Documentation Specialist you will be the first point of contact for questions related to cGMP (training, inspections, audits and documentation). In different team settings, you will work on the
maintenance and improvement of the available cGMP systems.

  • First departmental contact for questions about cGMP systems. 
  • Initiating and handling of compliance records (Change Control, non-conformances 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. 
  • 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
  • Lean green belt certification is preferred.
Other Information 
For more information please contact Carla Garcia at or +31 (0) 20 658 98 01.