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Doha

    Company marketing manager - Doha, دولة قطر - Snoonu

    Snoonu
    Snoonu Doha, دولة قطر

    منذ أسبوع

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    وصف
    The QAOperations Specialist is responsible for quality assuranceoversight of manufacturing, testing and supply chain operationswith current GMP regulations, procedures and qualitysystems.

    JobDuties

    Provide shopfloor quality oversight ofall production, quality control and supply chain departments toensure their practice fully adheres to cGMP, including dataintegrity. Ensure timely escalation to management of all applicableincidents.

    Perform live review of manufacturingbatch records in preparation for batch release and escalate anydiscrepanciesimmediately.

    Assist functional areas with achievingtimely and compliant final product disposition of theproduct.

    Review, approve and support proceduresand production/testing records as required and assist in thetraining of siteassociates.

    Ensure compliance of sitepersonnel and application of aseptic techniques and full complianceto sterile manufacturingregulations.

    Support FDA/Regulatory interactions forthe Indianapolis site activities and products to ensure successfulregulatory submissions andinspections.

    Support QA Operations as a valuedbusiness partner, with a culture of safety, quality, delivery topatients, cost, compliance and dataintegrity.

    Other relatedduties asassigned.

    This position involves shift work whichwill be defined through site start up and commercializationreadiness.

    This position involves on-call shifts, ifrequired, whenscheduled.



    Requirements

    EDUCATION:Bachelors Degree, preferably in Life Sciences, chemistryor related relevantdegree

    2+ years of experience in a GxPBiopharmaceutical manufacturingoperations

    1+ years of experience in a qualityassurancerole

    Collaborating across boundaries

    Functional Breadth

    QA and QC experience in biotechpharmaceutical industry with environmental monitoring &cleanlinesszones


    MUSTHAVE

    Knowledge of GMP and regulations,including FDA regulations (21 CFR Parts 211,212)
    Knowledge of IT Applications &tools
    QualityAssurance
    Quality Control (QC)Testing
    Quality Standards Strong organization,communication and presentationskills
    Excellent and effectiveinterpersonalskills

    Benefits

    PTO18 days (CompanyPolicy)

    Federal 6days

    EmployeeHealthcare we have four options; one of them we cover 100% for theemployee

    Life Insurance -Employee policy 100% covered byHCG

    Long TermDisability Insurance - Employee policy 100% covered byHCG

    Identity TheftInsurance - Employee policy 100% covered byHCG

    401K - with acompany match of up to3.5%

    HCGalso offer 401K ProfitSharing

    HCGTechnical - Company Laptop provided ifneeded

    HCGbrand items Clothing, Stationery, Quarterly care packs etc.

    We supportour diversity, equity, inclusion and belonging efforts because webelieve that by cultivating an environment where our diverseemployees can share their ideas and thrive, we will be able tobetter serve our organization and our global customers. Ourcommitment is that we have an inclusive culture that values each ofour employees background, by empowering our staff to feel valued,have a sense of belonging, make positive contributions to thecommunities in which they live and work, and be proud tobe part of Horizon ControlsGroup.



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