CSV Consultant with Mergers and Acquisition experienceother related Employment listings - Raritan, NJ at Geebo

CSV Consultant with Mergers and Acquisition experience

Position:
CSV Consultant with Mergers and Acquisition experienceLocation:
Raritan, NJ , USA/HybridDuration:
Long term contractJD:
:
Keywords - CSV, Computer System Validation, Tools validation, Quality Management System, 21 CFR 820, ISO 13485 , Acquisition and mergersIn addition to validation and regulation experience, the resource should have the following
Experience:
Roles and 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 teamsCSV, Computer System Validation, Tools validation, Quality Management System, 21 CFR 820, ISO 13485 , Acquisition and mergers Recommended Skills Acceptance Testing Consulting Iso 13485 Mergers And Acquisitions Quality Management Risk Analysis Apply to this job.
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