QC Supervisor质量控制主管社
10K-15K/月
宜昌市
发布时间:2023-09-06
职位描述
职位描述:
JobDescription职位说明书
JobTitle职位名称:QCSupervisor质量控制主管
Department部门:QualityDept质量部
Reportsto直接汇报上级:QCManager质量控制经理
JobLocation工作地点:YichangHubeiChina
JobSummary职位概述ThispositionisresponsiblefortechnicalsupportfortheYichangHumanwellcGMPOSDPlantinQualityControlandensuresthelabactivitiesandrelativeQCactivitiescomplywithcGMPlegalandregulatoryrequirementsandtheYichangHumanwellcGMPOSDPlantQualityManualandHSEPolicies.SupportsQAheadandcoachesQCtechnician.
EssentialResponsibilities
主要工作职责
EnsurethatthetestingandreleasingactivitycomplywiththerequirementsoftheYichangHumanwellcGMPOSDPlantPoliciesandmeetallrelevantcGMPregulatoryandlegislativerequirements.
EnsurethatrelativeQualitySystemandStandardOperatingProceduresareinplaceandthatcompliancewithcGMPismaintainedthroughtrainingandaudit.
Ensurethatthelogisticsforlabmanaged,QC/IPCtestingperformedasplannedandserveproductioneffectivelyandefficiently.EnsurethatQCprocessessuchassampling,reagent/referencestandardshandling,testingandrecording,OOE/OOSinvestigation,testingmonographimplementation,training,labequipmentqualificationandcalibration,testmethodtransferring,computerizedsystemvalidationaremanagedaccordingtocGMPandYichangHumanwellcGMPOSDPlantrequirement.
Trainjuniorstaffandprovideproblemsolving/technicalguideontestrelativeactivities.
ResponsibleforcorrectdatainelectronicsystemsintheQClaboratories.
Responsiblefortimelyimplementationofsafety,security,industrialhygieneandecologyregulationsinQualityControllabsandIPClabs.
BeavaluableteammemberofQualityorganizationanddevelopselfandothersthroughcloseteamworkandcrossfunctionalactivitiessuchascommunicationwithproduction&engineeringteam.
Teammemberforlaunchandtechnicalprojects.
NonEssentialresponsibilitiesN/A
Qualifications任职要求:
Bachelordegreeorabove,majoredinpharmaceuticals,chemistryorrelatedsciences.化学制药相关专业专科以上学历
OverthreeyearsofexperienceinproductionorQC有3年以上制药企业生产及质量工作背景
ExcellentEnglishinreadingandwriting;良好的英语读写能力
Responsible,excellentcommunicationandcoordinationskills,stronglearningability.有较强的责任感及良好的沟通能力
FamiliarwithcGMPandFDAregulationpreferred.参加过FDA或GMP认证者尤佳,具备内审员资格或供应商管理方面的经验者更佳。
其他要求
-
1人
- 生物工程
公司介绍
宜昌人福药业出口基地主要负责欧美固体口服制剂的出口。该厂完全按照美国FDA标准打造。现诚聘英才