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Framingham

    Quality Manager - Framingham, United States - The Fountain Group

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    Description

    Core Responsibilities include:
    Investigating and writing deviations, laboratory investigations, CAPAs, Tasks,
    Effectiveness reviews, and audit observation responses.
    Define and implement CAPAs, tasks, and effectiveness reviews with the
    assistance of QC Management
    Manage / own CCRs and liaise with functional QC units for work execution
    Conduct self-inspection / audit walkthroughs
    Support internal / external audits and participate in and / or lead the completion of
    responses to internal / external audit related observations / CAPA
    Conduct gap assessments against external and / or other Sanofi sites audit
    observations and assist with plan development to drive remedial actions.
    Maintain a high level of personal compliance to the required company standards
    and industry best practices
    Provide expertise during procedure / SOP revision process and function as DCR
    approver for department related SOPs, where required
    Partner with QC operations and manufacturing, where applicable, to support a
    culture of continuous compliance / improvement
    Assist in generating metrics at the required frequency to drive accountability and
    delivery of targets
    Requirements need to be quantifiable.
    Bachelor's Degree in science or technical field 6 years' of experience in biopharmaceuticals or related industry working in a regulated, GMP environment
    Or
    Master's degree and a minimum of 3 years' experience working in a regulated, GMP environment.
    #J-18808-Ljbffr

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