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    Project Engineer - Emory, United States - Amaris Consulting

    Amaris Consulting
    Amaris Consulting Emory, United States

    4 weeks ago

    Default job background
    Description
    Job Description Key Duties & Responsibilities:

    Develop and maintain change control procedures

    in accordance with regulatory requirements (e.g., FDA, EMA) and company standards.

    Manage the change control process

    from initiation through completion, ensuring timely review, approval, and implementation of changes.

    Collaborate with internal stakeholders

    (Quality Assurance, Regulatory Affairs, Manufacturing, Engineering) to assess change impact and develop appropriate mitigation strategies.

    Lead change control meetings and discussions

    to facilitate decision-making and ensure alignment among stakeholders.

    Evaluate proposed changes

    for feasibility, risks, and potential impact on product quality, compliance, and project timelines.

    Maintain accurate and up-to-date documentation

    related to change control activities, including change requests, assessments, and approvals.

    Monitor and track the status of change controls , ensuring timely closure and resolution of outstanding items.

    Provide guidance and support

    to project teams on change control requirements and best practices.

    Conduct periodic reviews and assessments

    of the change control process to identify areas for improvement and implement enhancements as needed.

    Participate in regulatory inspections and audits

    related to change control processes.

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