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    Compliance Lead - King of Prussia, United States - Themesoft Inc.

    Themesoft Inc.
    Themesoft Inc. King of Prussia, United States

    2 weeks ago

    Default job background
    Technology / Internet
    Description

    Job Title:Compliance Lead

    Location:King Of Prussia, PA (Hybrid Onsite)

    Duration: Long Term Contract

    Job Description:

    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 is able to 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

    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

    Able to author Validation Plan and compile Validation Summary Report and generates RTM

    Reviews and ensures that the Operational Procedure for the application is ready

    Is able to 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

    Good to have experience in implementing US-DSCSA

    Regards,

    Vignesh

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