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    Sr. Assoc, Quality - Ahmedabad, India - Baxter

    Baxter
    Baxter Ahmedabad, India

    1 week ago

    Default job background
    Full time
    Description

    This is where you save and sustain lives

    At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

    Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

    Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

    Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

  • To prepare, review and verify validation documentation such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and update Validation documentation templated as per requirements.
  • To prepare, review and verify the Computerised system validation documents such as User requirement specification (URS), Functional Requirement Specification (FRS), Design specification (DS), Configuration Specification (CS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Traceability requirement Matrix (TRM) and Validation summary report (VSR) etc.
  • To prepare, review and verify Gap analysis related to the Computerised system documents to identify the missing GxP documentation and created them as required by the company policies.
  • To actively engage in review of check lists, templates, format, test cases and test scripts for simple and better testing, better review of validation documents and easy understanding and assuring compliance of Computerised systems as per current regulatory requirements and industry best practices.
  • System administration for Computerized systems
  • To prepare an inventory of the computerised system and creation change control documents related to the software.
  • To play a major role in QC and manufacturing for computerised system validations
  • To train users and other team members in carrying out validation activities successfully.
  • To train the projects team members in Good documentation practices (GDPs) and ensure the completion of applicable standard operating procedure and validation trainings.
  • To investigate QC computerised systems related non-conformities, recommended corrective actions and review related technical reports.
  • To initiate and keep track of documents change request (DCR), Change control Management (CCM), Non-Conformity (NCR) and Corrective and preventive actions (CAPA) as per requirements in consultation with Sub-Department Manager.
  • To review and approve all recommendation points of GAP / risk assessment with respect to EU Annex 11, Gamp5, 21 CFR part 11 and other regulations.
  • To review and approve of all validation documents based on principle of ALCOA++ for validation docs.
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