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CSV Lead

Company

Katalyst Healthcares & Life Sciences

Location

South Plainfield, New Jersey, United States

Type

Full-time

Roles and Responsibilities:

  • Lead end-to-end Computer System Validation for GxP systems.

  • Develop and review URS, risk assessments, IQ/OQ/PQ protocols, and validation reports.

  • Ensure compliance with FDA 21 CFR Part 11, GAMP 5, and GxP.

  • Manage validation risk and maintain systems in a validated state.

  • Collaborate with IT, QA, Labs, and vendors.



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