125 days ago on altran.ch

CSV Consultant - IT Compliance f/m

Altran AG

  • Work region
  • Sector
  • Employment type
  • Position

 Please refer to JobSuchmaschine in your application

CSV Consultant - IT Compliance f/m

  • Job Title
    CSV Consultant - IT Compliance f/m
  • Reference Number
  • Work Site
    Switzerland / | CHE - All Regions / Zürich
  • Contract Type
    Permanent [Full-Time]

Your role

  •  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 GAMP5Design/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