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CSV Lead

Katalyst CRO, South Plainfield, New Jersey, us, 07080

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CSV Lead

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Katalyst CRO .

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.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Other

Industries

Pharmaceutical Manufacturing

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