Quality Assurance Specialist

WalkerColeInternationalissupportingawell-establishedpharmaceuticalwholesaledistributionorganisationinthesearchforaQualitySpecialisttojointheirQualityteam,basedinKent.

ThisisanexcellentopportunitytojoinaGDP-regulatedenvironment,workingcloselywiththeResponsiblePerson(RP)toensureproductsarestoredanddistributedsafelyandinfullcompliancewithEUGDPandHPRArequirements.Theroleoffersbroad,hands-onexposureacrossqualitysystems,complaintsanddeviations,supplierapproval,self-inspections,trainingandregulatoryinspections.

ThisrolewouldsuitaQAprofessionalwithatleastoneyear'squalityexperiencewhoislookingtobuildtheirGDPexpertise,withtheopportunitytodeputisefortheRP.

Youwillberesponsiblefor:

• EnsuringcompliancewiththeWholesaleDistributionAuthorisation,EUGDPGuidelines2013/C343/01andHPRArequirements.
• Handlingandescalatingcomplaints,returns,deviations,CAPAsandchangecontrols,ensuringtheyarerecorded,investigatedandclosedinatimelymanner.
• Managingsupplierandcustomerapprovalprocessesandmaintainingtheapprovedlists.
• ManagingSOPs,includingimplementingnewprocedures,trackingimplementationandsupportingannualdocumentationreviews.
• MaintainingthetrainingmatrixanddeliveringGDPandSOPtrainingtostaff.
• PreparingEUbatchreviewdocumentsforRPapprovalandrelease.
• SupportingtheRPwithproductrecalls,mockrecalls,andthemanagementofquarantined,returned,rejectedandfalsifiedmedicines.
• Supportingpreparationfor,andparticipatingin,regulatoryandcustomerinspectionsandself-inspections.
• CollatingqualityKPIsandtrendsforQualityManagementReviewmeetings.
• SupportingthemonitoringandupdatingofQualityAgreements,andparticipatinginriskassessments.

Thesuccessfulcandidatewillhave:

• Atleastoneyear'sexperienceworkinginaqualitydepartmentwithinthepharmaceuticalindustry.
• AgoodunderstandingofEUGDPguidelinesandHPRArequirements.
• Experiencehandlingdeviations,CAPAs,changecontrols,complaintsorreturns.
• ExperiencewithSOPs,documentcontrolandtrainingrecords.
• Strongattentiontodetail,withexcellentcommunicationandorganisationalskills.
• Theabilitytoworkcollaborativelyacrossdepartments,withaproactiveapproachtocontinuousimprovement.

QualitySpecialist|QualityAssurance|QA|GDP|GoodDistributionPractice|EUGDP|HPRA|ResponsiblePerson|RP|WholesaleDistribution|WDA|Deviations|CAPA|ChangeControl|SupplierApproval|Self-Inspection|Recalls|Pharmaceutical

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