Quality Assurance Assistant

- full-time -

The position

Responsible for the document control of all QA related documents.

Key responsibilities:

  • Issue, monitor and archive the documentation of quality assurance records and documents in the Document Management System (review of drafts, batch records and label issuance as outlined in the planning meeting)
  • Maintain and organize archiving of controlled documents (e.g. revised SOPs, assembly of batch documentation)
  • Handle the processing of change request forms.
  • Check that the documents are written in the right template format.
  • Arrange approval / signing of controlled documents.
  • Assure availability of latest version of controlled documents at recorded locations
  • Hand-out and distribution of draft versions, controlled copies and non-controlled copies of controlled documents.
  • Assure destruction of returned controlled copies.
  • Manage paper and electronic copies of controlled documents in draft and approved version.
  • Support for the QA officers on all documentation related activities.

Qualifications and skills:

  • Intermediate vocational education.
  • Good knowledge of MS Office.
  • Knowledge of GMP or Quality Systems is an advantage.
  • Good communication skills in English.
  • Accuracy, tidiness, self-organized, flexible, attention to detail, team player.

GMP Certification CMF Geleen

The Geleen Cell Manufacturing Facility was first GMP certified in 2012 by the Dutch authorities (IGZ).

Fact sheet

GMP Certification CMF Maastricht

Our Maastricht Cell Manufacturing Facility was first GMP certified in 2006 and has been successfully inspected by the Dutch Authorities (IGZ) on a regular basis thereafter.

Fact sheet