CSV Consultant

1 week ago

Raritan, New Jersey, United States Katalyst Healthcares & Life Sciences Full time
Responsibilities:
  • Minimum 7 years' Experience in the Validating IT software systems like Quality Management System in Life Sciences industry
  • Experience in FDA and/or Global regulated environment with good understanding of GxP standards like CFR 820 and Risk based validation.
  • Experience in validating Global Risk and Compliance modules.
  • Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory quality.
  • Knowledge of FDA guidance's and industry standards.
  • Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports).
  • Experience in reviewing system test and user acceptance test scripts, Traceability matrix related to System data Archival process.
  • Hands-on experience in software life-cycle management in System data archival process
  • Ability to provide Validation guidance, timely reviews, and escalations to Project teams.



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