QAResourceshaveanopportunityforaSrQCAnalystroletobebasedonclientsiteinEastCork:Contracttoyearend,ShiftroleRoleOverviewTheSeniorQCAnalystwillberesponsibleforperformingandoverseeinganalyticaltestingwithinaGMP-regulatedlaboratory,withastrongfocusonHPLC-basedmethods.Therolerequiresahighleveloftechnicalexpertise,dataintegrityawareness,andtheabilitytooperateindependentlywhilesupportingcontinuousimprovementandcomplianceinitiatives.Responsibilities(mayincludebutnotlimitedto):Performroutineandnon-routineanalyticaltestingusingHPLCtechniques,including:AssayandrelatedsubstancesImpuritiesprofilingDissolutionandcontentuniformitytestingExecutevalidatedanalyticalmethodsandensureadherencetoGMPrequirementsConductstabilityandshelf-lifetestingusingchromatographysystemsReviewanalyticaldata,includingchromatograms,integrations,andaudittrailsTroubleshootchromatographicandinstrumentationissueseffectivelySupportlaboratoryinvestigations,includingOOS(OutofSpecification)andOOT(OutofTrend)resultsEnsureallworkcomplieswithGMP,GDP,anddataintegrity(ALCOA+)principlesMaintainaccurateandcompletedocumentationinlinewithregulatoryexpectationsParticipateininternalandexternalaudits/inspectionsasrequiredSupportequipmentlifecycleactivities,includingIQ/OQ/PQ,calibration,andmaintenanceManageworkloadeffectivelyinahigh-throughputQCorstabilityenvironmentRequirements:Minimum4+years’hands-onexperienceinaGMPlaboratoryenvironmentStrongpracticalexperiencewithHPLCinstrumentation(e.g.Waters,Agilent,Thermo,Shimadzu)ProvenexperienceusingChromeleonCDS(ThermoFisher)ExperiencewithEmpowerorOpenLabisadvantageousDemonstratedexperiencein:RoutineHPLCtestingStabilitytestingMethodexecutionDatareviewandaudittrailassessmentStrongtroubleshootingandproblem-solvingcapabilitiesDegreeinChemistry,AnalyticalScience,PharmaceuticalScience,orrelateddiscipline(preferred)Desirable/AdvantageousExperiencementoringortrainingjunioranalystsExposuretoequipmentqualification(IQ/OQ/PQ)processesAuditandinspectionreadinessexperienceInterestedcandidatesshouldsendtheirCVtoniamh.mcdonald@peglobal.net
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