CSV Consultant
Company: Katalyst Healthcares & Life Sciences
Location: Raritan
Posted on: May 8, 2024
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Job Description:
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
Keywords: Katalyst Healthcares & Life Sciences, New Brunswick , CSV Consultant, Professions , Raritan, New Jersey
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