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IT Quality System Coordinator

Job Description

The main task of the Quality System Coordinator (QSC) is to create and maintain IT quality documents and also manage and/or perform the planning, implementation, closing and follow-up of IT projects .

The QSC works in close collaboration with representatives of the assigned functional area(s), expert colleagues, and with the Quality Compliance Managers to meet the applicable quality standards (GxP/ISO).

Your challenges and responsibilities:

  • Create and maintain IT Quality Documents (procedures & forms) for the IT department.
  • Guide the IT team through the requirements of the quality systems, and act as the first IT point of contact for any kind of support regarding quality.
  • Support audits (both internal and client audits) and manage deviations (CAPA process)
  • Initiate and follow up on periodic review of IT quality processes, documents, and ensure their revision when needed.
  • Evaluate on an ongoing basis that IT processes are effective, efficient, and consistently used throughout the IT team and in alignment with IT corporate guidelines.
  • Initiate process improvements / efficiencies where needed and possible.
  • Ensure, in collaboration with the functional area representatives, that training of employees on IT procedures is completed within the agreed timelines and that CVs and function descriptions are updated as required per SOP for each IT employees.
  • Create detailed project planning, update the project planning when required, establish and follow the budget and make sure progress is made.
  • Organize and lead project meetings and ensure timely communication to all concerned parties
  • Work in close collaboration with validation teams (computerized systems implementation), review and approve validation files as Technical Responsible.
  • Qualifications

  • Of course, you are both Quality and IT minded !
  • You have a professional or academic degree in Information Technology or equal through proven experience (at least around 4 years experience in a similar role; relevant experience in pharma is a big plus)
  • Good knowledge of IT procedures and quality systems .
  • Knowledge of the GxP/ISO27001/NIS2 regulations/norms is considered a significant asset.
  • Also considered to be an asset, is experience with Quality Management Systems or IT Project Management
  • You have good planning skills and good documentation practices (good writing skills!)
  • You are fluent in English (spoken and written). Moderate knowledge of Dutch and/or French is needed.
  • You have good observing capacities, a critical mindset (especially for IT systems) and are an easy learner, with a sense of responsibility, integrity, and diplomacy. You have good planning and organizational skills, and you have affinity with technology.
  • You feel at ease in multi-disciplinary teams and are a true facilitator.
  • You are a strong communicator, both towards management as well as throughout the organization and with clients.
  • You are willing to work in our different locations ( Mechelen, Antwerpen, Wavre).
  • And on top of this all you have a constructive, “can do” attitude!

    Please note we cannot support a work permit procedure.

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