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    QA Officer - Hayes, United Kingdom - Uniphar Group

    Uniphar Group
    Uniphar Group Hayes, United Kingdom

    13 hours ago

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    Description

    Who weare

    Uniphar Group is a rapidlyexpanding diversified healthcare services business with a globalfootprint and a proud heritage in Ireland. Since Uniphar became apublicly listed company in 2019, the Group has grown organicallyand through a series of strategic acquisitions, which continue tostrengthen Uniphar's international reach.

    Culture atUniphar

    We pride ourselves inbeing truly entrepreneurial, innovative, collaborative, with astrong problem-solving ethos. We have built working relationshipswhich span decades with many of the world's largest Pharma andMedTech companies. We believe that this is because we know how tobuild a relationship of trust with our partners - we put ourcustomers and their patients at the heart of what we do and treatthem with integrity and respect. Everything Uniphar does is enabledby our people. As we continue to grow domestically andinternationally, we become more diverse. This rich diversity fuelsour business and enriches our culture.

    Objective:
    TheQuality Officer is an integral member of the Quality Team, dealingwith aspects of Good Distribution Practice including qualitymanagement system, vendor management, Import and Export, Medicines,Medical Devices and other Healthcare Industry products. Work variesgreatly from day to day and, once full training is given, theincumbent will be expected to organize their workload continuously,with guidance from the TeamLeader.

    Essential:

    • Provenexperience of working within quality assurance in pharmaindustry
    • Experience in QMS, handling changecontrols, CAPA, deviations, riskassessments.
    • Knowledge and understanding ofUnlicensed Medicines regulations.
    • Experience inperforming technical checks on unlicensedmedicines.
    • Experience handling complaints,recalls, MHRA alerts andnotifications.
    • Essential computerised systemskills e.g., Microsoft Office.
    • Ability toquickly adapt to the new processes and various ITsystems.
    • Excellent organisationalskills.
    • Excellent attention todetail.
    • Good understanding ofconfidentiality.
    • Adapt to working underpressure in a fast-paced environment.
    • Abilityto work independently and within theteam.

    Desirable:

    • Knowledgeand understanding of storage and distribution of pharmaceuticalsunder GDP.
    • Knowledge and understanding ofregulatory requirement (MHRA)
    • Knowledge andExperience of working with Controlled Drugs (Home Officelicense)
    • Experience of usingQ-pulse.

    Main duties andResponsibilities:

    • Managementof Quality management system including CAPA, Deviation, ChangeControl, risk assessments, Root causeanalysis.
    • Assist with self-inspections,regulatory and customer inspections.
    • Handlereturns of medicinal products.
    • Management ofproduct recalls.
    • Investigate temperatureexcursions.
    • Creating / updating StandardOperating Procedures and workinstructions.
    • Completing drug and licenseapplications for import and export of drugs (HomeOffice)
    • CD licenseendorsements
    • Customer complaints investigationand closure
    • Dealing with product qualitycomplaints
    • Assist on quality functions tovarious departments.
    • Trending and monitoringactivities within the departments.
    • Reviewingdocuments for unlicensed medicines.
    • Request forpermissions to supply unlicensedmedicines.
    • Submission of NHS quarterlyreport.
    • Lease with translation serviceproviders for the review of translation of product informationleaflets and SPC's
    • Respond to technicalqueries.
    • Act as primary point of qualitycontact for unlicensed medicinesqueries.
    • Manage returnsprocess.
    • Other duties as instructed by theQuality Team Leader/Head of Quality &Compliance.
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