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Senior QA Engineer

  • Engineer, QA/QC

For the launch of a new project — where medical radioisotopes will be produced — we are looking for a senior QA Engineer to help build the quality systems and ensure audit-ready processes before the first production. You will work on QA procedures, validation reviews, and compliant operational workflows.

With your experience in GMP guidelines and strong knowledge of QA systems and validation, you will guarantee that the project operates in full compliance from day one.

Senior QA Engineer
  • Engineer, QA/QC
  • Mol
  • België
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Job details

Functie

The senior QA Engineer has both an executive and an advisory role within the CRF team:

  • Writing operational QA procedures, e.g., training, supplier qualification, (internal) audits, product release, etc.
  • Performing supplier qualifications
  • Reviewing validation plans, protocols, tests, and reports to achieve validated device/system/analytical method/cleanroom status
  • Reviewing operational documents, e.g., material specs, incoming goods inspection, etc.
  • Issuing controlled copies, e.g., batch records
  • Reviewing performed tests, e.g., method validation, engineering batch records, etc.
  • Ensuring compliance regarding Annex 1, Annex 3, Annex 11 / FDA 21 CFR Part 11
  • A (master’s) degree in a scientific field (engineering, chemistry, biomedical, pharmacy)
  • +10 years of relevant work experience in a GMP environment, QA, and validation
  • Experience in setting up and implementing entirely new QA processes
  • Experience with the startup of a new production facility is an advantage
  • A communicative and proactive attitude; an initiator with a hands-on mentality and the necessary discipline to complete projects through to successful validation.
  • Willing to perform inspections in a controlled environment where radioactive materials are handled (without coming into direct contact with these substances).
  • An engaging role with the necessary responsibility
  • Personalized follow-up in your professional activities
  • The opportunity to grow further within your field
  • A competitive salary supplemented by fringe benefits (freelancers are also eligible)
  • The chance to participate in high-profile projects

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