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Jersey City

    CSV Engineer/Expert - Jersey City, United States - eTeam

    eTeam
    eTeam Jersey City, United States

    2 weeks ago

    eTeam background
    Description
    Roles & Responsibilities:
    • Perform review for GxP and non-GxP systems to ensure compliance with regulatory requirements
    • Experience on decommission and data integrity (ALOCA+)
    • Experience in supporting Data Migrations from validation perspective
    • Working knowledge on end-to-end validation of GxP applications
    • dept with Agile and Waterfall methodology-based software development and has prior experience in Computer System Validation using Agile methodology
    • Reviews - Requirement Specifications, Functional Specifications/ User Stories / Acceptance Criteria and ensures completeness of test script with traceability
    • Ensures Risk Assessment is completed for all the requirements and test cases are designed In reference to the risk levels identified for the requirements
    • Performs review of pre-executed test protocol which includes all the basic elements of a test script, completeness and appropriateness of the test case to the requirement
    • Ensures pre-executed test protocol has the necessary test data requirements to run the tests
    • Reviews post-executed test protocols for the completeness, accuracy of the results and evidence and enables team on the defect management process
    • ble to author Validation Plan and compile Validation Summary Report and generates RTM
    • Performs Change Requests Implement and Close Change Request which includes to check for the application controls and associated documentation process for end to end Change Request process
    Prior experience in using tools like ALM, Document Management Systems(EDMS), ServiceNow and JIRA
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