Change Control Coordinator

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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