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    Sr Assoc, Quality - Ahmedabad, India - Baxter

    Baxter
    Baxter Ahmedabad, India

    3 weeks ago

    Default job background
    Full time
    Description

    This is where you contribute to saving and improving lives

    At Baxter, we are united by our mission. Regardless of your position, your work has a positive global impact, enhancing outcomes for millions of patients. Join our community where success and inspiration thrive, allowing you to excel.

    Baxter's innovative products and therapies play a vital role in healthcare facilities worldwide, driving significant medical advancements for over 85 years.

    Together, we foster a supportive environment where we can all achieve our best. Step into the realm of making a difference in lives — where your dedication fuels our mission.

    • To oversee the implementation and upkeep of Quality Management System components on-site.
    • To ensure compliance with quality metrics in alignment with Global Quality standards.
    • To promptly submit quality metrics data to QA Head and management.
    • To effectively track and execute improvement objectives identified during quality metrics reviews.
    • To assess the department's efficiency and provide essential training to team members from various functions.
    • To manage Electronic Quality Management System (E-QMS) modules efficiently across plants.
    • To conduct thorough investigations of non-conformities (NCR/SNCRs), identify root causes, and implement corrective actions swiftly.
    • To review/approve and oversee investigations of Out of Specifications (OOS) results and take necessary actions within specified timelines.
    • To ensure proper investigation of Out of Trend (OOT), Out of Limit (OOL), and Laboratory Investigation Reports (LIR).
    • To prepare/review trend reports for QMS elements and ensure recommendations are executed.
    • To review/approve Change Control Management (CCM) & Document Change Request (DCR) as per SOP.
    • To regularly monitor and maintain key performance indicators, ensuring targets are met.
    • To establish data reliability measures, conduct site management and review meetings on time.
    • To participate in CAPA review board and monthly quality metrics review meetings promptly.
    • To assist in both external and internal audits, ensuring proper archival of QMS documents.
    • To report audit observations related to QMS compliance.
    • To communicate cross-functional requirements to relevant personnel and departments.
    • To offer support to quality functions as needed by the business.
    • To alert key management colleagues regarding critical quality-affecting QMS aspects.
    • To escalate any potential deviations that could impact quality metrics from regular trends to management.
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