Job Description

I.T. Systems Validation Expert

Responsibilities:

  • Develop project validation plans and generate summary reports

  • Evaluate risk assessment and functional requirements specifications (FRS)

  • Act as liaison between quality assurance and project team

  • Help drive each phase of the project lifecycle including ascertaining requirements, risk assessment, change / release management

    • Qualifications:

  • Bachelors degree in business / I.T. or comparable education & experience

  • 5 years minimum experience in computer systems validation including authoring and execution of IOQ/PQ’s and strong familiarity with cGMP/GLP/GAMP5/GALP.

  • Must be familiar with all phases of a systems development life cycle.

  • SAP, LIMS , Empower would be considered assets

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