Summary
About the Role
Change Control Coordinator
About the Role:
Handling of technical change control as well as responsibility for the documentation and coordination of the necessary activities during plant changes in Agile
Key Responsibilities:
- Should have good engineering knowledge in the Bio-Pharmaceutical Plant in the areas of
- Facilities that are involved as infrastructure or in the manufacturing process, e.g. Ultrapure water systems, building services, manufacturing, packaging equipment (direct and indirect impact systems)
- the qualified status of a room or its classification (cleanroom zone E, D, C, B, A).
- the software and computer systems managed by Engineering.
- for new acquisitions of plants and systems/Equipment’s
- on measuring equipment
- SAP/Quality Management system software skills
- Project planning Skills
- Asset life cycle management skills eg maintenance documents and its metrics review
- Should have sound knowledge about the Nomination of all participants in the QMS change phase from reviewer – approver.
- Should be good in all Engineering related changes which requires an evaluation & followed by a Registration Representative
- Changes to ER/ES relevant systems, must be evaluated by eCompliance
- In the case of devices, a DHF (Device Documentation File) evaluation may also be required. In the case of combination products, assembled and/or packaged, the MS&T "device expert" must check for adjustments with regard to device documentation (DHF file).
- Implementation of the change and processing (or delegation) of the tasks defined in the implementation plan
- Coordination of the change until completion
Essential Requirements:
- 5+ years of experience in handling change controls within pharmaceutical sector
- Very good knowledge of German and good knowledge of English (spoken and in writing)
- Experience in the GMP or pharmaceutical sector.
- Technical education, high level of personal responsibility, good communication skills
Desirable Requirements:
- Degree or equivalent experience in Engineering with experience in Pharmaceutical Industry/ specifically GMP background
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