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    Computer System Validation Engineer - Bangalore, India - TD Newton

    TD Newton
    TD Newton Bangalore, India

    1 day ago

    Default job background
    permanent Technology / Internet
    Description

    Your key responsibilities :

    Technical Excellence :
    Perform assessments of computer systems and processes for Life Sciences clients (compliance with internal procedures, leading practices, and regulatory requirements)

    • Create/review CSV deliverables like user requirements, system specifications, Validation Plan, Qualification Plans, SOPs, IQ/OQ/PQ, Traceability matrix, Design Specs, and validation summary reports
    • Provide guidance and oversight of validation activities for projects involving GxP relevant computer systems
    • Work closely with project team members to incorporate appropriate elements of quality and compliance into the system lifecycle
    • Review and approve computer system validation work products, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables

    Skills and attributes :
    To qualify for the role you must have :

    • Experience in Quality and Compliance with hands-on computer system validation experience on Enterprise Applications (SAP ECC/HANA, LIMS, QMS, ELN, DMS, PLM, CRM, CTMS, RPA etc.)
    • Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation.
    • Experience with validation/ testing tools like HPALM, Azure DevOps (ADO) etc. will be an added advantage.
    • Experience in training validation resources will be an added advantage.

    Qualification :

    • A graduate degree from a reputed University

    Experience :

    • 3 to 12 years of experience

    What we look for :

    • People with the ability to work in a collaborative manner to provide services across multiple client departments while following the commercial and legal requirements.


    You will need a practical approach to solving issues and complex problems with the ability to deliver insightful and practical solutions.


    We look for people who are agile, curious, mindful and able to sustain positive energy, while being adaptable and creative in their approach.

    )
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