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 (Gx.P/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.
