Quality Engineer

Key responsibilities:

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• Responsible for the quality oversight and regulatory aspects of the assigned CAPEX project
  
• Ensuring C&Q compliance of GMP systems related to the aseptic fill-finish facility (equipment/utilities/facilities) during the project management lifecycle from design engineering through to the initial C&Q and handover phases
  
• Reviewing and approving C&Q documents of GMP systems as well as related changes and deviations
  
• Supporting audits and regulatory inspections (Swissmedic, FDA, etc.)
  
• Providing leadership and guidance to project team members on C&Q strategy and issues
  
• Ensuring that decisions are fully supported by global and local Quality, as well as Regulatory
  
• Escalating issues in an open and timely manner and take leadership for their resolution
  

Key requirements:

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• Bachelor or Master's degree in Engineering, Life Sciences or related field
  
• Significant experience in the GMP regulated pharmaceutical industry, preferably in a role within a Quality Unit
  
• Experience in a QA role for the C&Q of GMP systems related to aseptic fill-finish processes and facility (filling equipment, lyophilization, clean utilities, and clean room facilities)
  
• Fluent in English, German would be an advantage