GMP Compliance Specialist

Vor 4 Tagen


Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions AG Vollzeit
Senior Quality Assurance Engineer

We are seeking a highly skilled CQV Engineer to join our team in the Stein area, Switzerland. The successful candidate will be responsible for ensuring that CQV activities are executed in accordance with CORP 35, the C&Q Plan and supporting Validation Plans.

Key Responsibilities:
  • Act as C&Q SME for High Bay warehouse scope - cold and ambient (high preference).
  • Support C&Q execution for key main equipment and small support equipment in Building 413.
  • Coordinate commissioning activities and execution activities with CSV Team and global IT teams.
  • Lead C&Q testing activities supported by vendors and contractors.
  • Develop validation plans related to scope of execution.
  • Update Master C&Q Plan and supporting plans during project execution lifecycle.
  • Interface with other disciplines such as HSE, Automation, Electrical, Instrumentation, Operation and Engineering.

Requirements:

  • Relevant working/residency permit or Swiss/EU-Citizenship required.
  • Experience in use of Kneat for documentation development and execution.
  • A relevant Third Level or Professional Qualification.
  • Ability to work well under pressure and within strict deadlines.
  • 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 a High Bay warehouse (ambient and 2 to 8 degree cold room) necessary.
  • Proactive and able to work independently.
  • Considerable experience with cGMP.
  • Strong interpersonal and communication skills.
  • Fluent English (C1 Level), German an advantage.


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