PrincipalDutiesandResponsibilities
ParticipateinthedailyactivitiesoftheQADepartmentasassigned.
WorkasdirectedtoestablishandmaintainQualitySystemstoensurethemanufacture,testinganddistributionprocessescomplywithapplicableregulatoryrequirements.
ParticipateintheinternalauditingprogramforJHLWuhanChina,asrequired.
ParticipateintheexecutionoftheProductComplaintSystemandassistwithproductreturn,withdrawalorrecallactivities,asneeded.
ProvideQAinputonGMPFacilityandGMPUtilitiesissuessuchasqualification/requalification,changes,maintenance,startups/shutdown,disasterrecovery,etc.
MaintaincomplianceoftheEnvironmentalMonitoringandValidationprograms.
CreateandreviseQualityAssurancerelateddocumentsinsupportofGMP.
Identifytrainingneedsandorganizetraininginterventionstomeetqualitystandards.
ReviewandapprovalofdatafordeterminingthedispositionofGMPmaterial(rawmaterial,in­process,drugsubstance,finishedproduct,packaging,labelingandmanufacturingcomponents)andthereviewandapprovalofdocumentsanddataassociatedwiththeStabilityProgram.
Assistinhostingregulatory,customerorduediligenceinspections.Workcloselywithalldepartments,asassigned,toensuretimelyresponsesandfollowupofanyobservations.
AssistQADocumentControlinmanagingtheCAPA,DiscrepancyandChangeControlsystems.

JobRequirements
BSdegree,scientificdisciplinepreferred.
2-5years’experienceinaQualityregulatedindustry,pharmaceuticalormedicaldeviceexperienceispreferred.Experienceinthebiosimilarqualityenvironmentisaplus.
ProficiencyintheuseofMicrosoftOfficeApplications.
Mustbeself-motivatedwithabilitytoindependentlyhandle,organizeandprioritizemultipletasksandabletoperformunderpressuretomeetdeadlines.
In-depthknowledgeofGMPsandrelatedguidelinesandregulatoryrequirements.
GoodoralandwrittencommunicationskillsinEnglishandMandarin(Read,Write,Verbal)demonstratedbycommunicatingeffectivelywithotherfunctionsandmanagementprocesseswithinQualityAssuranceandmulti-disciplinaryteams.