QC经理工作职责与职位要求.docx

该【QC经理工作职责与职位要求 】是由【碎碎念的折木】上传分享，文档一共【5】页，该文档可以免费在线阅读，需要了解更多关于【QC经理工作职责与职位要求 】的内容，可以使用淘豆网的站内搜索功能，选择自己适合的文档，以下文字是截取该文章内的部分文字，如需要获得完整电子版，请下载此文档到您的设备，方便您编辑和打印。QC经理工作职责与职位要求
职位描述:
职责描述:
负责试验室的综合治理和体系建立,负责制定、修订及维护试验室治理规程,保证QC试验室的高效运转并符合GMP、CFDA要求;
负责检测方法确实认和验证,审核验证方案、记录以及验证报告;负;负责建立、修订以及升级检测方法标准操作规程及相应记录,并监视其有效实施;
负责试验室检测数据的分析、统计及汇总;
负责审核日常分析试验记录、检验报告、仪器校准和设备使用记录、清洁记录、取样记录、留样记录等,并进展复核和推断,保证质量标准的有效实施;
负责监视原始纸质记录的治理和保存以及电子数据的保存和备份,使其符合数据真实性、完整性要求;
负责关注和跟踪分析技术的进展以及相关法规的更新,并知道试验室相关标准操作规程的维护和更新;
负责监视全部物料、试剂、培育基、设备等的治理;
负责对各项特别状况进展调查、分析;
负责组织开展申报资料的撰写和审核以及与注册部门的沟通和协调。
职位要求:
硕士以上学历,药物分析学、分子生物学、或相关专业及教育背景;
5年以上生物制药及cGMP相关质量治理阅历;
熟识药品GMP标准,有FDA审核阅历者优先;
良好的临床申报资料撰写及审核力量,有获得临床批件以及生产批件阅历者优先;
良好的团队领导力及协作力量。
篇2:QualityManager汽车行业质量经理-美资500强工作职责与职位要求
职位描述:
JobResponsibility:
LeadWeifangqualityfunctionforallactivitiesfromIQC,&MVSMs.
Communicateswithabovementionedfunction,regulatoryandorganizationalrequirementstoassureproductqualityandcustomersatisfactioninWeifanglocation.
OverseesWeifangE&MeffectivedocumentationandimplementationofthequalitymanagementsystemIATF16949toassurecompliancewithcustomerandregulatoryrequirementsandthestandardssetbycorporate/divisionpoliciesaswellasconsolidationcoordinatorofQMSforoneCFD.
WorkswithWeifangE&MBUM,productionlineandothersupportingfunctionstoensurethatindividualsperformingfunctionsaffectingqualityaretrainedanddemonstratetheappropriateskillsandperformanceresults.
Coordinatesnecessarypersonnelforinternal,customerandthirdpartyqualitysystemaudits.
Maintainsacorrectiveactionsystemtoanalyzeandcorrectnonconformingconditionsandcomplaints.
Implementstheperformancemeasurementsnecessarytoeffectivelyevaluateorganizationalperformanceandtrendsinproductquality,services,.
Monitoring/Supportsupplierqualitytoensuredesiredlevelsofsupplierqualityperformance.
CollaborateswithEngineeringonbothnewproductdevelopmentanddesignreviewforquality/reliabilityissues.
TrainingdeliveryofthequalitymanagementsystemandotherqualityprofessionalknowledgestoallWeifangfunctionsandkeysuppliers.
Supportandtakeinitiativetothedivisionproductsimplificationandpartssimplification.
Qualifications:
.
.
FivetoTenyearsofQuality,Engineeringorrelatedexperience,E&Mfilterindustryexperienceismust.
ThoroughknowledgeofIATF16949asapplicableforautomotiveismandatory.
Knowledgeofmanufacturingandqualitytechnologies.
Experiencewithqualityimprovementtoolsandtechniques(.,APQP,SixSigma,StatisticalProcessControl,andFMEA,MSA,CP).
Demonstratedleadership,projectmanagement,facilitationandproblem-solvingskills.
GoodInterpersonalcommunicationandnegotiationskills.
GoodSelf-Managementandteamspirit,,underpressure.
Beabletosummarizecomplicatedinformationintoshort,sharptothepoint.
GoodPCandEnglishlanguageknowledge,writtenisnecessary,oralisaplus.