CSV - Computer System Validation - Greater Bengaluru Area, India - MNC Group

    MNC Group
    MNC Group Greater Bengaluru Area, India

    2 weeks ago

    Default job background
    Upper Management / Consulting
    Description

    Role:CSV - Computer System Validation

    Job Location: Bangalore

    Exp Required: 5-10 years

    · Experience in Quality and Compliance with hands-on computer system validation experience

    · 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

    · Experience in FDA regulated environment with good understanding of cGxP (cGMP, cGDP, cGAMP, cGLP) standards and Risk based validation

    · Review and approved computer system validation work products, assuring thoroughness of validation planning and making appropriate progress towards timely completion of validation deliverables

    · Experience in training validation resources will be an added advantage

    · Experience in performing assessments based on 21 CFR Part 11 and Annexure 11 requirements.

    · Experience in SAP

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