Job Description


Senior TRACKWISE Validation Analyst

Contract role - 6-12++ months

100% Remote - Client located in California (must work Pacific time hours)
  • Description:
    • Initial validation of TrackWise performed on 2021 for modules QMS, TMS and DMS + configurations
    • Challenges: RTM not complete and deviation management deficient
  • Scope of work for Consultant:
  • Re-validation for the update to the latest released version of TrackWise (Summer 20 à Winter 22)
  • Validation of new configuration changes
  • Client will provide:
    • URS updated
    • TWD off the shelf validation and configuration test scripts executed in initial validation
    • Traceability Matrix from initial validation (not complete)
  • List of deliverables expected:
* Configuration Specifications (update existing CS)
* Validation Plan (update existing VP)
* OQ/PQ (test scripts): only updates and execution needed
* Traceability Matrix: very important that all URS are traced, not only the new ones. Partial RTM available
* Validation Report

Additionally we will also need:
  • Approach of how deviations would be handled
  • List of assumptions of the quote and estimated hours i.e: do you think the processes for PQ/regression testing, are likely to be impacted with/without configurations during the upgrade?



Dawn West
AdeptSource

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