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制药行业岗位职责
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QAManager-制药行业Responsibilities:
Inchargesitequalitycontrol,qualitysystemmanagement.
Setupthecompanyqualitygoalandregularlyreviewthestatusofqualitytarget.Trainandguidetheteamtoreachfunctionalqualitygoal.
ManageengineersandinspectorsteamofQAsection,coordinatewithotherdept./team.
Definethequalityassurancepolicyandprocess,leadtheimplementationofqualityassurancemodelsandsystemthatcanguaranteetotheorganizationcustomersatisfaction,continuousimprovementandorganizationaleffectivenessinordertoachievemaximumcompetitiveness.
Prepareweeklyandmonthlyqualityreports,makecontinuousqualityimprovementthroughgoodteamwork
Connectcustomerneedswiththeconditionsoftheproductionprocessanddefineproductguidelinesandcriteriaandtheconditionsofthemanufacturingprocess.
Qualitymanagementsystemimplement,monitorandmaintain.Conductregularinternalqualityauditstoensureitseffectivenessandsuitability.
EnsurethattheQualityManagementSystem(QMS)iseffectivelyestablished,implementedandmaintainedtobeincompliancewithISO9001,ISO13485,21CFR820,CEStandardsandChineseGMP.
Manageallinspectioninstrument,inspectiongages,andtestfixtures/tooling/equipment.
Requirement:
10+qualitymanagementexperience,5+sitequalitycontrolexperienceinpharmaceutical,IVDormedicaldeviceindustry
Peoplemanagementexperience
ExperiencedinISO13485,21CFR820,GMP,QSR
FDAinspectionexperience
Soundknowledgeinprocessqualitycontrolandriskmanagement
Stronginleadership
Goodatcommunication,coordination
FluentinEnglish
Responsibilities:
Inchargesitequalitycontrol,qualitysystemmanagement.
Setupthecompanyqualitygoalandregularlyreviewthestatusofqualitytarget.Trainandguidetheteamtoreachfunctionalqualitygoal.
ManageengineersandinspectorsteamofQAsection,coordinatewithotherdept./team.
Definethequalityassurancepolicyandprocess,leadtheimplementationofqualityassurancemodelsandsystemthatcanguaranteetotheorganizationcustomersatisfaction,continuousimprovementandorganizationaleffectivenessinordertoachievemaximumcompetitiveness.
Prepareweeklyandmonthlyqualityreports,makecontinuousqualityimprovementthroughgoodteamwork
Connectcustomerneedswiththeconditionsoftheproductionprocessanddefineproductguidelinesandcriteriaandtheconditionsofthemanufacturingprocess.
Qualitymanagementsystemimplement,monitorandmaintain.Conductregularinternalqualityauditstoensureitseffectivenessandsuitability.
EnsurethattheQualityManagementSystem(QMS)iseffectivelyestablished,implementedandmaintainedtobeincompliancewithISO9001,ISO13485,21CFR820,CEStandardsandChineseGMP.
Manageallinspectioninstrument,inspectiongages,andtestfixtures/tooling/equipment.
Requirement:
10+qualitymanagementexperience,5+sitequalitycontrolexperienceinpharmaceutical,IVDormedicaldeviceindustry
Peoplemanagementexperience
ExperiencedinISO13485,21CFR820,GMP,QSR
FDAinspectionexperience
Soundknowledgeinprocessqualitycontrolandriskmanagement
Stronginleadership
Goodatcommunication,coordination
FluentinEnglish
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