Quality Assurance Officer

- (full-time) -

The Position

In this role, you are responsible for planning and execution of daily quality assurance activities while ensuring compliance with international quality requirements as defined by the applicable guidelines (e.g. FDA, EMA, ICH) and all existing GMP standards in the area of responsibility. This position involves judgement of batch related documents.
You are a proactive thinking team-player, accurate, precise and constructively critical.

 

Tasks and responsibilities:

  • Plan and execute quality assurance activities (document management, batch records and label issuance, batch record review, equipment and supplier qualifications etc.) including documentation.
  • Monitor compliance with all applicable GMP and safety standards.
  • Support the Qualified Person in his role, including audits and quality training.
  • Write, review and approve documentation (SOP’s, manufacturing and quality instructions, validation of protocols and reports, non-conformities, change requests). Handle, distribute and archive controlled documents.
  • Prepare data for trending (QRB, Annual Product Review) and support internal and external audits.

Qualifications and skills:

  • BSc in chemistry/biotechnology. Knowledge of GMP 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