CQV Lead (m/f/d)

Main responsibilities:

  • Ensure that CQV activities are executed, the C&Q Plan and supporting Validation Plans.
  • C&Q SME warehouse scope - cold and ambient.
  • Support C&Q execution for key euipment (Semiautomated and fully automated visual inspection machine), other small support equipment (thawing units, fridges, freezers, cold /freezer rooms)
  • Coordination of execution activities with supporting CSV Team and global IT teams.
  • Lead C&Q testing activities supported by external vendors and/or contractors.
  • Develop any supporting validation plans related to scope of execution.
  • Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.
  • Interface and with other disciplines: HSE, Automation, Electrical, Instrumentation, Operation and Engineering
  • Generate, review, approve, CQV test scripts in accordance with verification plans and any applicable site commissioning or validation plans or procedures.
  • Lead the management of change for his area elements and ensures that the change is controlled, communicated and implemented in the most cost effective and timely manner
  • Ensure C&Q execution milestones are completed as per baseline schedule
  • C&Q field execution completed in a safely manner and following Lonza HSE standards. This will include preparation of Lock-Out-Tag-Out, PSHR completion, Method Statements.
  • Support the C&Q execution team as Kneat Super User.

Your background

  • Minimum of 8 Years extensive experience in areas/systems under future responsibility.
  • Preferably Diploma level degree in Mechanical or Chemical Engineering.
  • Previous experience in authoring CQV lifecycle documents necessary
  • Previous experience in qualifying warehouse (ambient and 2 to 8 degree cold room) necessary
  • Field CQV execution experience.
  • Considerable experience with cGMP
  • Experience in use of Kneat for documentation development and execution

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Facts about the job

Country
Switzerland
Location
Aargau
Contract type
Contracting
Job-ID
J6Y7X3&origin=51001
Company
Coopers Group AG