CSV Consultant
2 weeks ago
Raritan, 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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CSV Consultant
2 weeks ago
Raritan, NJ, United States Katalyst Healthcares & Life Sciences Full timeResponsibilities: 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...