Senior QC Analyst

QAResourceshaveanopportunityforaSrQCAnalystroletobebasedonclientsiteinEastCork:

Contracttoyearend,Shiftrole

RoleOverview

TheSeniorQCAnalystwillberesponsibleforperformingandoverseeinganalyticaltestingwithinaGMP-regulatedlaboratory,withastrongfocusonHPLC-basedmethods.Therolerequiresahighleveloftechnicalexpertise,dataintegrityawareness,andtheabilitytooperateindependentlywhilesupportingcontinuousimprovementandcomplianceinitiatives.

Responsibilities(mayincludebutnotlimitedto):

• Performroutineandnon-routineanalyticaltestingusingHPLCtechniques,including:
• Assayandrelatedsubstances
• Impuritiesprofiling
• Dissolutionandcontentuniformitytesting
• ExecutevalidatedanalyticalmethodsandensureadherencetoGMPrequirements
• Conductstabilityandshelf-lifetestingusingchromatographysystems
• Reviewanalyticaldata,includingchromatograms,integrations,andaudittrails
• Troubleshootchromatographicandinstrumentationissueseffectively
• Supportlaboratoryinvestigations,includingOOS(OutofSpecification)andOOT(OutofTrend)results
• EnsureallworkcomplieswithGMP,GDP,anddataintegrity(ALCOA+)principles
• Maintainaccurateandcompletedocumentationinlinewithregulatoryexpectations
• Participateininternalandexternalaudits/inspectionsasrequired
• Supportequipmentlifecycleactivities,includingIQ/OQ/PQ,calibration,andmaintenance
• Manageworkloadeffectivelyinahigh-throughputQCorstabilityenvironment

Requirements:

• Minimum4+years’hands-onexperienceinaGMPlaboratoryenvironment
• StrongpracticalexperiencewithHPLCinstrumentation(e.g.Waters,Agilent,Thermo,Shimadzu)
• ProvenexperienceusingChromeleonCDS(ThermoFisher)
• ExperiencewithEmpowerorOpenLabisadvantageous
• Demonstratedexperiencein:
• RoutineHPLCtesting
• Stabilitytesting
• Methodexecution
• Datareviewandaudittrailassessment
• Strongtroubleshootingandproblem-solvingcapabilities
• DegreeinChemistry,AnalyticalScience,PharmaceuticalScience,orrelateddiscipline(preferred)

Desirable/Advantageous

• Experiencementoringortrainingjunioranalysts
• Exposuretoequipmentqualification(IQ/OQ/PQ)processes
• Auditandinspectionreadinessexperience

InterestedcandidatesshouldsendtheirCVtoniamh.mcdonald@peglobal.net