岗位职责
Aboutthejob:Ourteam/OverviewTheRegionalHubManufacturing&Supply(M&S)ServicesisresponsiblefordeliveringandsupportingM&SteamsinpartnershipwithBusinessandDigital,anddrivepriorityandtransformativeinitiativesacrossM&S.TheteammembersofRegionalHubM&SQualityServices(ProductComplaints)willactaspartnersincarryingouttasksandfulfillingresponsibilitiestosupportidentifiedandestablishedglobalqualityprocessestotheGlobalhub.TheRegionalHubProductTechnicalComplaintsteamhandlesintakeactivitiesofcomplaintprocessing.Mainresponsibilities61HandleProductTechnicalComplaints(PTC)formedicaldevices,pharmaceuticalproducts,biologics,andcombinationproducts,ensuringcompliancewithregulatorystandards.61Collaboratewithinternal/externalstakeholdersviaCrossfunctionalteams,Manufacturingsites,CustomerService,MedicalInformation,Pharmacovigilance,SalesAssociates,Regulatory,CommercialOperations,Legal,andRiskManagementdepartmentsforcomplaintmanagement.61Ensuretocompletealltraininginatimelymanner.61Processintakeforcomplaintsandevaluate,ensuringtimelyprocessingandclosureofthecomplaints.61Participateinad-hocmeetingsforproduct-specificcomplaintissuesandprovidefeedbackoncomplaintinvestigations.61ManagesandensuresthecomplianceofallQualityprocessesanddocumentationwithapplicableregulations/Sanofistandards.HandleQMSrecords&anydiscrepanciesandensurecompletionwithindefinedtimelines.61EnsurethedocumentationofHubrelatedGxPactivities.61Anyotherresponsibilitiesasassigned/alignedbymanager.61Distributionofinquiry/complaintsreceivedwithinteamforfurtherprocessing.61Facilitateperiodicgovernancemeetingswithrespectivestakeholdersandcreationofpresentations,SOPs,andtrainingmaterials.61Periodicreportdownloadsfromrelevanttoolstoensureallthecomplaintsarereceived,processed&closedintimelymanner.61PerformqualitychecksonPTCactivitiesandsupportaudits/regulatoryinspections.61Striveforcontinuousimprovementbyfollowingstandardization,simplification,digitalizationtoachieveefficiency.Requirem
工作地址
成都-温江区 (成都天府大道北段1199号成都银泰中心3座) 查看地图
