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King of Prussia

    Validation Lead - King of Prussia, United States - Talent Groups

    Talent Groups
    Talent Groups King of Prussia, United States

    4 weeks ago

    Default job background
    Accounting / Finance
    Description

    Must Have Skills: CSV, SAP Validation, Product Serialization, DSCSA

    Roles and Responsibilities – Regional System Assurance Lead

    • 10years' Experience in Validating SAP systems in Manufacturing
    • Experienced in CSV activities in Manufacturing related applications like SAP Systems, Product Serialization systems, MES systems.
    • Perform review for GxP systems to ensure compliance with regulatory requirements.
    • Working knowledge on end-to-end validation of GxP applications and can perform document/process Compliance Analysis
    • Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System Validation using Agile methodology.
    • Able to author Validation Plan and compile Validation Summary Report and generates RTM.
    • Can handle Change Requirement related implementation for small changes - responsible for Implementation Plan, Impact Assessment, Test Plan/ Results, Defects and RTM
    • Prior experience in using tools like ALM, DMS and JIRA


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