QAManager

Responsibilities:- ResponsibleforOSDQAteamdailymanagement- Developandimplementconsistentprocessesandsystemsthatassurequality,GMP,andcompliance- PromotethecontinuousdevelopmentofQualityAssuranceofOSDproductionline- CommunicatewithotherAZsitesregardingtoqualityissues- EnsureOSDQAreviewandapprovalofGMPdocumentationthathasdirectimpactontheactivities,equipmentandfacilities- EnsurecompliancewithallGMPandregulatoryrequirements- Reviewproductionsheetandreleaseproduct- EnsuretofulfilltheKPIsofQA- Qualitycontinuousimprovement- Returnedgoodshandling- Samplingandretainedsamplemanagement- Stabilitymanagement- Complaintinvestigation- Annualproductreview- EstablishandmaintainqualitymanagementsystembasedonGMPrequirements- Ensureregulatorycomplianceofqualitymanagementsystem- SHEresponsibilitiesRequirements:- Universitygraduate,majorinpharmaceuticalorrelatedsubjects- ComprehensiveknowledgeofinternationalGMPrequirements,qualitysystems,andpharmaceuticalmanufacturing/packagingtechnologies- Comprehensiveknowledgeofregulatoryagencyinteractionsandcomplianceprocedures- ComprehensiveunderstandingofLeanconcepts&
applications- Familiarwithnewproductintroductionprocess- KnowledgeofProcesscontrol&
capabilitymethodology,forexampleCpk,FMEA- AbilitytoeffectivelybalanceandmanagethechallengescreatedbyacceleratedfinishedproductdeliveryschedulesandtheneedtoensureallqualityrequirementsareaddressedpriortothereleaseofthefinishedproducttoAZcustomers- 10yearsplusexperiencewithinQAinthepharmaceuticalindustry,withatleast5years- supervisory/managerialroles- GoodEnglishinwritingandspeaking- GoodComputerskill- WorkingknowledgeofMicrosoftapplications,SAPorsimilarsystem阿斯利康声明：1.
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