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    Validation Engineer - Jersey City, United States - Katalyst HealthCares & Life Sciences

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    Description
    Responsibilities

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    Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.


    You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.

    Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems

    Create and modify validation documentation including but not limited to:

    User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements

    Reports which summarize the results of the protocol executions

    Exception reports which identify defects or issues during test execution Review vendor documentation

    Requirement Specification document review and approvals

    System Implementation Plan Review

    System Implementation Summary Report Review

    Review and Pre-Approve ST/UAT Test Scripts in ALM

    Create, Update RRA (Regulatory Risk Assessment) and obtain approvals

    Post Execution Review and Post Approvals in ALM

    gR Implementation Approvals

    Retirement Plan Revew

    Requirements:

    Requirement document

    Validation/Test Plan

    Requirement Traceability Matrix

    Change Requests

    Impact assessment document

    Test/Validation Summary Report

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