15 days ago on jobs.ch

CSV Consultant - IT Compliance f/m

Altran AG

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CSV Consultant - IT Compliance f/m

Area of Responsibility:

  • Preparing, executing, and finalizing the validation of computerized systems 
  • Preparing, executing, and finalizing the validation of equipment
  • Providing guidance, project management and reporting activities 
  • Setting up and maintaining IT solutions and services under regulatory requirements
  • Coordinate and document validation activities; preparation/approval of protocols

Your Profile:

  • Master in Computer Sciences
  • 3 years of experience in CSV projects
  • Extensive knowledge of the FDA 21 CFR Part11, regulations and guidelines
  • Relevant experience in Automation and DCS
  • Knowledge in Quality Risk Management
  • Experience in User Requirement Specification (URS) and testing
  • Handling of product category 3, 4 & 5 from specification to verification under GAMP5
  • Design/Installation/Operation/Performance Qualification (DQ, IQ, OQ, PQ) of Equipment
  • You speak German fluently and are capable to deliver on time and with high quality
  • You are mobile for projects in the German part of Switzerland