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Quality Assurance Engineer/Consultant

Your role

  • You are responsible for complaint handling, change control, deviations, CAPA, etc;
  • You ensure the compliance to standards (FDA, EMA, ICH, ISO,…);
  • You take on the QA Qualification of equipment, facilities and utilities;
  • You create the Product Quality Reviews (PQR) and the Continued Process Verifications (CPV);
  • You take on the role as project manager within the QA department and make sure of the follow-up on all aspects;
  • You are responsible for the follow-up of operational QA during production or distribution of supplies;
  • You manage the planning and execution of internal audits;
  • You are the trainer for all GMP related topics within the department of the client.
  • Your profile

  • Master in engineering or related scientific subject;
  • A high professional level of Dutch and above average proficiency in English;
  • At least 1 year of experience in Quality Assurance in a GMP environment;
  • Knowledge of the pharmaceutical, medical devices, biotechnology and/or diagnostics industry;
  • A natural mature mindset, extensive communicative skills and able to successfully cope with complexity;
  • Mobility towards the Antwerp province in Belgium.
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