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Computer System Validation Expert (GxP)

In collaboration with our Quality and technology teams, you will assist in the setup and maintenance of the Quality Management System for Computer System Validation (Policies, VMP, Standard Operating Procedures, Instructions and Templates)

You will be responsible for:

  • the preparation of the documentation required for computer system validation (change control, risk assessment, URS, traceability matrix, test plan, validation plan, validation report etc.),
  • The execution and documentation of tests as part of computer system validation,
  • The execution and documentation of infrastructure validation,
  • The qualification of computer system / software suppliers,
  • Periodic evaluation of the validated computer systems and subsequent reporting

Your role will be to:

  • Act as Subject Matter Expert regarding CSV during regulatory inspections and client audits as well as selection and qualification of contract parties,
  • Work closely with the product owner and project manager within the tech team to translate findings and requirements into use-cases and technical sprints,
  • Work with the tech team leads to advocate quality thinking and increase the awareness of working within a validated environment.
Apply now

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