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Doha

    Company marketing manager - Doha, دولة قطر - Snoonu

    Snoonu
    Snoonu Doha, دولة قطر

    منذ 5 أيام

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    وصف
    The QA Operations Specialist is responsible for quality assurance oversight of manufacturing, testing and supply chain operations with current GMP regulations, procedures and quality systems.

    Job Duties

    Provide shopfloor quality oversight of all production, quality control and supply chain departments to ensure their practice fully adheres to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.

    Perform live review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.

    Assist functional areas with achieving timely and compliant final product disposition of the product.

    Review, approve and support procedures and production/testing records as required and assist in the training of site associates.

    Ensure compliance of site personnel and application of aseptic techniques and full compliance to sterile manufacturing regulations.

    Support FDA/Regulatory interactions for the Indianapolis site activities and products to ensure successful regulatory submissions and inspections.

    Support QA Operations as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance and data integrity.

    Other related duties as assigned.

    This position involves shift work which will be defined through site start up and commercialization readiness.

    This position involves on-call shifts, if required, when scheduled.



    Requirements

    EDUCATION: Bachelors Degree, preferably in Life Sciences, chemistry or related relevant degree

    2+ years of experience in a GxP Biopharmaceutical manufacturing operations

    1+ years of experience in a quality assurance role

    Collaborating across boundaries

    Functional Breadth

    QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones


    MUST HAVE

    Knowledge of GMP and regulations, including FDA regulations (21 CFR Parts 211, 212)
    Knowledge of IT Applications & tools
    Quality Assurance
    Quality Control (QC) Testing
    Quality Standards Strong organization, communication and presentation skills
    Excellent and effective interpersonal skills

    Benefits

    PTO 18 days (Company Policy)

    Federal 6 days

    Employee Healthcare we have four options; one of them we cover 100% for the employee

    Life Insurance - Employee policy 100% covered by HCG

    Long Term Disability Insurance - Employee policy 100% covered by HCG

    Identity Theft Insurance - Employee policy 100% covered by HCG

    401K - with a company match of up to 3.5%

    HCG also offer 401K Profit Sharing

    HCG Technical - Company Laptop provided if needed

    HCG brand items Clothing, Stationery, Quarterly care packs etc.

    We support our diversity, equity, inclusion and belonging efforts because we believe that by cultivating an environment where our diverse employees can share their ideas and thrive, we will be able to better serve our organization and our global customers. Our commitment is that we have an inclusive culture that values each of our employees background, by empowering our staff to feel valued, have a sense of belonging, make positive contributions to the communities in which they live and work, and be proud to be part of Horizon Controls Group.



    EDUCATION: Bachelor\'s Degree, preferably in Life Sciences, chemistry or related relevant degree 2+ years of experience in a GxP Biopharmaceutical manufacturing operations 1+ years of experience in a quality assurance role Collaborating across boundaries Functional Breadth QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones MUST HAVE Knowledge of GMP and regulations, including FDA regulations (21 CFR Parts 211, 212) and ICH Knowledge of IT Applications & tools Quality Assurance Quality Control (QC) Testing Quality Standards Strong organization, communication and presentation skills Excellent and effective interpersonal skills
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