PositionDescription:
AsthecentralqualitycontactfortheElancoMarketingAffiliateorganization,theQUALITYMANAGERadvises,decidesreports,consultsandescalatesqualitymattersrelatingtoElancoproductsdistributedinChina,totheappropriateaffiliatemanagement,SeniorRegionQualityManager,RegionalQualityLeaderorCorporatemanagementwhenneeded.
Functions,Duties,Tasks:

COREJOBTASKS
? Beresponsibleforproductqualityrelatedmatters,escalateanylocalproductqualityrelatedissuetotheSeniorRegionQualityManager,RegionalQualityLeaderandtheaffiliatemanagement,andcollaborateinanylocalactiontobetakenasaresultofthat(i.e.recall,counterfeitetc.)
? ImplementandmonitorproductqualitysystemsandQualityManualintheMarketingaffiliate.
? Assistaffiliatemanagement,SeniorRegionQualityManager,RegionalQualityLeaderinassuringthatalloperationsoftheaffiliatecomplywiththeAffiliateQualityManualandotherapplicablecompanyqualitystandards,GQPandlocalregulations.
? ExecutetheassessmentplanforGMPServiceProviders.
? CreateandreviseQualityagreementscoveringaffiliateprocessesforGMPserviceproviders.
? Demonstratecontinuousimprovementandminimizeriskbyaroutineself-assessment,correctiveandpreventativeactions(CAPA),anduseofaQualityPlan.

SPECIFICAREASOFACCOUNTABILITY/RESPONSIBILITY
1. QualityManagement
? EnsureaffiliatecompliancewithGoodManufacturingPractices(cGMP),GoodWarehousingpractices,GQPandgoodLocaltestingpracticesforfinishedproducts.Alsoensureaffiliatecompliancewithallrelevantlocalregulations.
? Conductquarterlytrends(events,complaints,approvals).
? Ensureanannualmanagementreviewisconducted.
? EnsureNotificationtoManagementwithinonedayofidentification.
? Halt,holdorquarantineproductstatusasrequired.


BatchRelease
? Ensureproductsreceivedcomplywiththemarketauthorization,byapproving/rejectingbatches.
? WhereQCtestingofAPI(ActivePharmaceuticalIngredient)isalocalregulatoryrequirement,ensureGoodManufacturingPractices(GMP)isfollowed

ChangeandEventManagement
? Create,executeandclosechangecontrolsthatmayaffectthequalityattributesoftheproduct.Assistwithmanagementofthechangecontrolsystem.
? Createandresolvedeviations(events)fromnormalproceduresthatcouldpotentiallyimpactsafety,identity,strengthandqualityoftheproduct.Ensuredeviationcompletioniswithinrequirementsandcorrectiveandpreventativeactionsarecompletedbytargetdate.

Documentation
? Maintainlocalprocedureswhichreflectlocalregulations(whererequired)andcorrespondingglobalqualitystandards.
? Createorreviewrelevantqualityrelateddocuments.
? Ensurerecordretentionofdocumentationasperappropriaterecordretentionperiod.

PersonnelQualifications
? MaintainajobdescriptionandCVthatdescribesthequalitydutiesandreviewiteverytwoyears.
? Review,andapproveGMP,GQPtrainingmaterialgeneratedbythelocalaffiliateandensuretrainingrecordsaredocumented

QualityPlan
? DevelopandexecutetheQualityplantocorrectandpreventrecurrenceofsignificantqualityproblemsfromaudits,self-inspections,deviations,recalls,productcomplaintsorsignificantchanges
? EnsurecompliancetotheAffiliateQualityManual,otherapplicablecompanyqualitystandards,GQPandrelevantlocalregulationsbycompletingqualitysystemmaintenanceactivitiesbytargetduedates
? AdheretoandmeetQualityplanactionstargetduedates.

AuditingandInspections
? Conductself-assessmentsofqualitysystemsatleastannually,tomaintainastateofinspectionreadinessattheaffiliate.
? AssessGMPsuppliersandserviceproviderswhereapplicableaccordingtoanapprovedplan.

RegulatoryInteractionswithGovernmentAgencies
? Provideinformationrequiredforreportingtoglobalmanagementsuchasbutnotlimitedtositenotificationofaregulatoryinspection(announcedandunannounced),requestsforregulatoryresponsestoproductqualityrelatedmatters,agencyrequestsforsamples(rawmaterials,intermediates,activepharmaceuticalingredientordrugproduct)andcommunicationsofpotentialrestrictiononproductsupplytomanagementandregulatoryagencies
? Participateincommunicationstotheregulatoryagenciesonaproductqualityrelatedmatter.

AdverseEventsandProductComplaints
? EnsureaprocessisinplacetoreportadverseeventsandproductcomplaintsasperElancoQualitystandardandlocalregulations
? Ensureaprocessisinplacetomanageproductcomplaints,datacollection,assessment,action,notifications,closurewithinrequiredtimelines,trendingandrecordretention.
? Investigateproductcomplaintsasrequiredtoensureclosurewithinrequiredtimelines.
? Providequalityoversightofcallcenterstoensurethequalitysystemismaintainedinacompliantwayandreportingrequirementsaremet.
? Ensuretimelyresponsetocustomersifnecessary
? RepresentproductcomplaintsinMarketingAffiliateinspectionsasneeded

MaterialsManagement
? Ensureasystemisinplacetomanagethehandling,accountabilityandtraceabilityofinventoryincludingfreegoodsinaccordancewithlocalregulationsandlabelstorageconditions
? EnsureQualityapprovalofpromotionalitemsthathaveapotentialtoimpacttheproductqualityorsafetyofthecustomerand/oranimal
? RequestinconsultationwiththeSeniorRegionQualityManagerandRegionalQualityLeader,approvalfromtheGlobalQualityLeaderofthedecisionmakingprocessforredistributionofanyrejected,recalledandcounterfeitproduct

DistributionofFinishedProducts
? Ensureproductshippedfromonemarketingaffiliatetoanothermeetsthemarketingauthorizationofreceivingcountry.
? Consultonoperatingtemperatureandhumidity(whereapplicable)rangesforstorageareas
? Ensureinventorycyclecountsareperformedannually.
? Investigatesignificantconfirmedcyclecountdiscrepanciesusingthedeviationprocess.ConsultwiththeSeniorRegionQualityManagerandgainapprovalonadjustmentsoutsideofacceptedtolerances


MinimumQualification(education,experienceand/ortraining,requiredcertifications):
Skills:
? PCSkills–Microsoft;SAP,Word,Excel,andOutlook
? Analytical/investigationalskills
? Inventorymanagementknowledgehighlyregarded.

Attributes:
? Attentiontodetail
? CustomerFocus
? Excellentinterpersonalandcommunication(writtenandoral)skills
? Strongorganizationandplanningskills
? Abilitytoprioritizeandmanagecompetingtasksandtimelines
? Self-managed
? Teamworkskills

Experience:
Atleast5yearsQualityexperienceinaGMP/GSPenvironment.

Qualifications:
? TertiaryqualificationsinScienceorrelatedfield
? RegisteredPharmacist(ifrequiredbylocallaws)
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