Qualified Person Biotechnology Operations - Eli Lilly and Company
  • Limerick, Munster, Ireland
  • via BeBee.com
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Job Description

We'relookingforahighlymotivatedanddetail-orientedQualifiedPersontojoinourqualityassuranceteamandensurethehigheststandardsofproductqualityandcompliance.brbrbJobOverview:/bbrbrTheQualifiedPersonplaysapivotalroleinensuringthequalityandregulatorycomplianceofourbiopharmaceuticalproducts.Keyresponsibilitiesincludeprovidingtechnicalleadership,implementingqualitymonitoringprograms,reviewingandapprovingdocuments,andsupportingregulatorysubmissionsandbatchapproval.brbrbKeyResponsibilities:/bbrbrulliProvideQualityleadership,direction,trainingandgovernance.brliMonitorGMPcomplianceandverificationoftheeffectiveimplementationofkeyGMPprogramsandsystems.brliApprovequality-relateddocumentsandreviewchangecontrols,deviations,andproductqualitycomplaints.brliEnsuremanufacturedbiotechdrugsubstancebatchesarecertifiedandbiotechdrugproductbatchesaretestedincompliancewithregulations.br/ulbrbBasicQualifications:/bbrbrulliBSc,MSc,orPhDinBiology,Chemistry,Pharmacy,orrelateddiscipline.brliMustbeapprovedbymemberstateasalicensedQPinordertobenamedonthecompanylicenceasaQP.br/ulbrbAdditionalskills/experience:/bbrbrulliMinimumof10yearsofexperienceinqualityassurancewithinabiotechnologyorpharmaceuticalmanufacturingenvironment.brliStrongunderstandingandworkingknowledgeofcGMP,FDA,DataIntegrity,QualityRiskManagementandotherbiopharmaceuticalregulatoryrequirements.br/ulbrbrbApplynowandjoinateamdedicatedtomakinglifebetterforpeoplearoundtheworld./b

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