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FDA Software Validation Consultant

FDA Software Validation Consultant

  • Provide guidance and oversight of FDA device and software validation projects
  • Take ownership for planning and execution of validation activities
  • Author validation documentation associated with FDA device and software validation
  • Work closely with project team members to incorporate appropriate elements of quality and compliance into the system lifecycle

Position Requirements

  • 8+ years experience in Quality and Compliance with substantial hands-on computer system validation experience
  • Experience in FDA regulated environment
  • Experience with Change Control processes
  • Experience with FDA and other international regulations (e.g. 21 CFR Part 11, Annex 11)
  • Knowledge of FDA guidance’s and industry standards
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