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CSV Consultant with Mergers and Acquisition experience (Onsite)

W3Global Inc
Raritan, NJ Full Time
POSTED ON 4/24/2024

Must Have: Computer System Validation, Quality Management System, Acquisitions and Mergers

Keywords - CSV, Computer System Validation, Tools validation, Quality Management System, 21 CFR 820, ISO 13485 , Acquisition and mergers

In 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





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