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GMP Warehouse Specialist

vor 2 Wochen

Aarau, Aargau, Schweiz EPM Scientific Vollzeit

EPM Scientific is currently seeking a highly skilled and motivated GMP High Bay Warehouse Specialist to join our team in Stein.

The successful candidate will be responsible for driving the execution and coordination of defined CQV activities in the warehouse for both cold and ambient temperatures and support building.

Key Responsibilities:
  • Ensure that CQV activities are executed in accordance with CORP 35, the C&Q Plan, and supporting Validation Plans.
  • Support C&Q execution for key main equipment: Semi-automated and fully automated visual inspection machine, other small support equipment (LAF, thawing units, fridges, freezers, cold/freezer rooms, etc.), including alignment with execution approach of equivalent systems in QC building.
  • Execution of commissioning activities related to allocated areas or systems.
  • Coordination of execution activities with supporting CSV Team and global IT teams.
  • Lead C&Q testing activities supported by vendors and contractors.
  • Develop supporting validation plans related to scope of execution.
  • Support updates of Master C&Q Plan and supporting plans during project execution life cycle.
Requirements:
  • Minimum of 8 years extensive experience in areas/systems under future responsibility.
  • Diploma level degree in Mechanical or Chemical Engineering.
  • Previous experience in authoring CQV life cycle documents necessary.
  • Considerable experience with cGMP.
  • Experience in use of Kneat for documentation development and execution.