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QA Compliance Officer

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Sophie Steels
Career Manager



Sophie Steels
Career Manager
+32 496 49 18 21


Job description

  • Within the QA operations department we are looking for a QA specialist for production plant . In this position you are responsible for quality support for the introduction and project integration of multiproduct launch unit
  • Drafting and reviewing Quality documentation in the context of the project (Project notes, Quality plans, ...)
  • Follow up and review of general project documentation (risk assessments, validation plans, procedures, batch records, ...)
  • Sharing quality support and expertise related to clinical manufacturing vs commercial manufacturing
  • Prepare and review project documentation (e.g. procedures, risk assessments) with a view to deviation prevention (DPP) and human error prevention (HEP)
  • Be in compliance with SOPs, global standards, regulations and product registration (filing) related to clinical and commercial manufacturing
  • Provide quality support for process validation activities
  • Execution of GEMBA (e.g. follow-up of physical project works, shakedowns, Deviation prevention, ...)


Profile

  • Master in a scientific direction or equivalent through experience
  • Knowledge and interpretation of cGMP in a regulated environment
  • Knowledge and interpretation of clinical manufacturing and regulations is an advantage
  • Knowledge and experience with Quality Processes and Quality Assurance
  • Superb accuracy and attention to detail
  • Independence and a strong sense of responsibility
  • An enthusiastic team player and strong in communication
  • Good writing skills
  • Good knowledge of the English language


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Related vacancies

Senior Quality Officer/Specialist


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+32 496 49 18 21