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    Assoc, Quality - Ahmedabad, India - Baxter

    Baxter
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    Full time
    Description

    This is where you contribute to saving and improving lives

    At Baxter, our mission deeply unites us. Regardless of your role within the organization, your work has a positive impact on individuals globally. You will experience a strong sense of purpose as our collective efforts enhance outcomes for countless patients.

    Baxter's renowned products and therapies are utilized in virtually every medical facility worldwide, including clinics and homes. With over 85 years of experience, we have been at the forefront of revolutionary medical advancements that revolutionize healthcare.

    Together, we foster an environment where happiness, success, and mutual inspiration thrive. This is where you can truly excel.

    Join us at the convergence of life-saving and life-sustaining initiatives—where your dedication propels our shared mission forward.

    • To plan, execute, compile, and review equipment, utility, process validation, cleaning validation, and facility qualification protocols.
    • To collaborate with cross-functional teams from various departments to ensure the smooth execution of all validation activities and promptly report any deviations to the Supervisor.
    • To create monthly and yearly schedules for different qualification and validation processes, subject to review by the Supervisor and approval by the Manager.
    • To oversee Quality Management System (QMS) components such as Change Control Management, Corrective and Preventive Action, Out of Specification (OOS) incidents, and non-conformances related to validation activities. Prepare investigation reports and ensure timely closure of QMS documents in Trackwise.
    • To review the upcoming validation activities based on the calendar and provide necessary details to the cross-functional and PPA departments well in advance for effective planning.
    • To oversee sample withdrawals during process validation and promptly update the Supervisor on any discrepancies.
    • To ensure proper online documentation of executed protocols and thorough completion of observation sheets for process validation and other qualifications.
    • To verify the closure of respective documents through the CFS process.
    • To liaise with projects and other cross-functional departments to stay informed about upcoming equipment installations, prepare protocols in advance, conduct new equipment qualifications, and seek approval from the Supervisor.
    • To participate in training sessions for each protocol before commencing any validation and qualification activities.
    • To gather data and compile summary reports for submission to the International Regulatory Affairs (IRA) in response to queries and Abbreviated New Drug Application (ANDA) requirements.
    • To update protocols in line with current regulatory standards to enhance validation documents.
    • To develop Validation Master Plans (VMP) in accordance with regulatory guidelines or audit compliance needs, subject to review and approval by the Supervisor.
    • To ensure validation documents are kept up-to-date from a Good Manufacturing Practice (GMP) perspective as per regulatory expectations, along with planning and executing validation activities linked to QMS elements.
    • To report any activities or issues encountered during shift-related validation tasks in daily meetings.
    • To review and authorize documents related to Validation activities and operational processes.
    • To participate in internal and external inspections and complete assigned trainings promptly.
    • To maintain a keen focus on safety aspects, record hazards, or any near-miss incidents in the designated portal.
    • To undertake any additional responsibilities as delegated by the Supervisor.

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