Quality Assurance Specialist - Kolkata - beBeeRegulator

    beBeeRegulator
    beBeeRegulator Kolkata

    1 week ago

    Job title: Quality System Manager

    Description

    Job Overview


    The Quality Systems Manager will oversee and strengthen quality systems to ensure regulatory compliance and continuous improvement across pharmaceutical manufacturing operations.



    • Manage core quality systems including Deviations, CAPA, Change Control, Training, and Document Control.

    • Evaluate ongoing compliance with cGMP and FDA regulations (21 CFR Parts 210 and 211).

    • Leverage investigative skills for root cause analysis and reviews of corrective actions.

    • Support audits such as customer inspections, internal examinations, or those initiated by the Food & Drug Administration.

    • The role is focused on advancing best practices within our organization’s quality management system.

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