ToassisttheRC/QMSSectionManagerinensuringsiteregulatorycompliancetoGSK&regulatorystandards.
Toensureregistrationdocumentsforproductsaresubmittedcorrectly.
Toensureinternalauditsystem,QMSsystemeffectively.
SupporttoprepareandhostL4inspections.
Toensurepackagestandardsamplecheckingiseffectiveandaccurate.
WorkwithProcurementShareServicegroupandSupplierQualityShareServicegrouptoensureeffectivesupplierqualitymanagementinGSKTsite.
Establishandmaintaindocumentcontrol,archiveandsecuritysystem,BOMandAPIsystem,SOPtrainingmatrixsystem.
TobeTCofmylearningsystemofcompliancetraining.
CheckandcontrolthedocumentsystemaccordingtoGMP.

KeyResponsibilities主要岗位职责:

1. Generalresponsibilities:

? Beresponsibleforthepreparing,reviewing,andupdatingofSOPsrelated.
? PerformQMSgapanalysisforrelevantpoliciesandtraining.
? UnderstandandcomplywiththeapplicablelocalregulationsofQuality,EHSandothers,GSKstandardsforQMS,EHSSetc.andcompanypolicy.Adherencetostandardoperatingprocedures
? TroubleshootinginRC/QMSarea
? PerformotherjobsassignedbyRC/QMSSectionManager.


2. Specificresponsibilities:

RegulatoryCompliance
? Prepareproductregistrationdossierandsamples.
? SupportNPIteamtopreparenewproductintroductionrequiredsubmissiondossier.
? Prepareapplicationdocumentforchangingmanufacturingcertificatefornewproductaddition.
? Maintainnew/updatedregulationfollowupprocessandensuretheappropriategapanalysisisconducted.
? Archivingandmaintainingregistrationdossierrelatedtothesite.
? ConjunctionwithGMSRegulatoryAffairsDepartmenttoestablishtheChinaregulationsinformationdatabaseinensuringsiteregulatorycompliancetoChinaregulatorystandards.
? Conducttrainingrelatedtoregulationsforrelevantdepartmentsaccordingly.
? MaintainSiteMasterFillSystemandtimelyupdatedaccordingtorelevantchange.



QMS
? SupporttomaintainQMSimplementationsystematGSKT,circulateQMSreleaseinformationandtrackgapanalysis.
? EnsureallCAPAarisingfromQMSgapanalysisistrackedeffectively.
? PrepareandmaintainGMPorientationtrainingmaterial,annualGMPtrainingmaterial.DeliverGMPorientationtrainingtonewstaff.

Recall

? MaintainsiterecallSOPthroughQMSgapanalysis。
? Communicatewithregulatoryauthorityduringrecall
? ArchivethemeetingminutesandmaintainLICandPIRClist


InternalandExternalaudit
? Maintaininternalauditingsystem,prepareannualL2auditscheduleandcoordinateeachL2audit.
? MaintainL1inspectionsystem,followupL1inspectionadherencewitheachdepartment.
? FamiliarwithL1inspectionprocess,conductL1inspectioninRC/QMSSection.
? ConductL2inspectiononschedule.
? EnsureallCAPAarisingfrominternalauditistrackedeffectively.
? MaintainCARISMA3data,enterL4report,enterfindings,CAPAsofL3andL4audits,andfollow-upandcloseinatimelymanner.
? PrepareandmaintainGMPorientationtrainingmaterial,annualGMPtrainingmaterial.DeliverGMPorientationtrainingtonewstaff.
? SupportonL3andL4audits.

ChangeControl
? LeadChangeControlmeetingandmaintainChangeControlsystem

Packagematerialcompliance
? Preparepackagingcomponentstestmethods,specifications/STD.
? Reviewartwork,standardsamples.
? Maintaineffectivespecificationsystem,maintainrelevantdatabase,makesurebothhardcopy,e-versionestablish,distribution,archiving,retrieve,destroyfullycomplywithSOP,QMSandGMPrequirements.

Suppliermanagement

? LeadtheprocessofSupplierQualificationinthesite,workingwithSQandPPtoachievethis.
? Supplierchangemanagement.Followsitechangecontrolprocesstogetthechangeinitiated,followupandclose.WorkingwithSQandPPtogetnecessarysupport.
? Communicateswithsuppliersensuringtheyunderstandsitequalityrequirements.
? MaintainthesupplierqualityKPIsanddrivetheimprovement.
? Conductsupplierperformancereviewusingmaterialcomplaintanalysis.
? SupportPPforsupplierperformancereview.

DocumentControl
? GSKTallproductsrelatedmanufacturing,packagingBOM,itemnumber,APIsystemcontrol,upgradeandmaintain,BPCSsystemmaintainaccordingtoapprovedBOM,itemnumber,APIhardcopies.
? Establishandimplementdocumentcontrolsystemtoensurequalitystandard,SOPs,batchrecords,specification,andregistrationdocumentinplace.
? Establishthecleardocumentarchivesystem,ManageQualityfilecenters,tomakesureeasilydocumentretrieval.
? MaintaintheSOPsystem,makesurethatSOPcanbeupdatedandreviewedtimely,nooutdatedqualityrelateddocumentsinuse.
? Responsibleforsiteinformationsecuritysystem,leadthecoordinatorsofeachdepartmenttoimplementinformationcontrolaccordingtotherequirement.
? Responsiblefordocumentmasterlistupdateandmaintenan
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