QC验证主管岗位职责任职要求
QC验证主管岗位职责
JobSummary:
EnsurethemaintenanceandqualificationoftheanalyticalandmetrologicalequipmentoftheNovacylQualityControlLaboratory;
Supportnon-routineanalyticactivitiessuchasAnalyticalvalidation,AnalyticaltransfersandMethodtroubleshooting;
ManagetheanalystsinchargeofQualificationandvalidationactivities(resourcesfromtheHPLCandphysicalchemistrylaboratorysecondedtotheQualification/validationprojects).
Mainsmissions:
Maintenance/Qualificationoflaboratoryequipment;
Managementofanalyticaltransferandvalidations.
Mission1:Maintenance
?Organizesthepreventivemaintenance(internalorexternal)andtheperiodicverifications(internalorexternal)oftheequipmentofthelaboratory(planning/follow-upofthesupplier)intherespectofthedeadlinesandcosts
?Organizesthecurativemaintenanceoflaboratoryequipmentduringbreakdowns(internalorexternal)(planning/monitoringofserviceproviders)
?Managesstocksofsparepartsneededforfirst-levelmaintenance
?Representsthemaintenancepoleduringauditsandinspectionsbytheauthorities
?Supportslaboratorytechniciansincaseofequipmentproblems
?Organizescalibration/verificationofstandardsdedicatedtoequipmentverificationbyexternalagencies
Mission2:QualificationLaboratoryEquipment
?Writetheequipmentqualificationdocumentationforthelaboratory(URS,protocols....)
?Organizequalificationbysuppliers
?Conductand/ororganizeadditionaltestsnotperformedbysuppliers(internaloroutsourced)
?Writetheequipmentusagedocumentation(operatingmodes,logbooks...)
?Presentsqualificationrecordsduringauditsandinspectionsbytheauthorities
?Ensuresthetrainingoftechniciansintheuseofequipment
?Organizesequipmentsupplierqualification
?Participatesinthechoiceoflaboratoryequipmentandsoftware
Mission3:Coordinationofanalyticaltransfer,validationsandtroubleshootingactivities
?Supportsthetechniciansincaseofanalyticalproblem,technicalOOS,technicalquestion?Writethestudyprotocols/reportforthelaboratoryoffstreamactivities(analyticalvalidation,transfer...)?Organisewiththelaboratorystaffthestudiesforoffstreamactivities(analyticalvalidation,transfer...)
?Participatesinthecreation/modificationoftheworkingdocumentation(analyticalmethods,workinstructions…
Mission4:Laboratorylife
?Participatestovariousmeetingsrelatedtotheoperationoftheservice(daily,monthly...)?Leadsactionstoimprovetheoperationofthemaintenancecenterandthelaboratory.?Defineswiththemanagertheinvestmentstrategyforlaboratoryequipment?Isthesystemadministratorofthelab'sSI
Requiredskills:
1.Bachelordegreeinrelevant;
2.With5-10yearsprofessionalexperienceinaQualityControllaboratoryinaGMPenvironment;
3.SpokenEnglishisaplus;
4.Goodknowledgeofthestandardsapplicabletothelaboratory(pharmacopoeia,.ICH...);
5.Goodunderstandingofequipmentandanalyticallaboratorytechniques(Titration,GC,HPLC,Spectroscopy,KarlFischer,....);
6.Knowledgeofsoftwarerelatedtolaboratoryequipment.
QC验证主管岗位
篇2：产品验证主管岗位职责
实验室主管+产品验证美埃(中国)环境净化有限公司中山美埃净化技术有限公司,美埃职责描述:
1、新开发、改进产品的性能、可靠性的实验验证和评价;
2、针对售后问题进行产品、关键元器件市场投诉问题分析;
3、产品新引进风机、电路板等关键资材对整机系统的影响评估和实验验证;
4、协助及跟进完善整机整改流程;
5、根据市场及售后问题完善评价体系、标准制度、体系建设;1、新开发、改进产品的性能、可靠性的实验验证和评价;
6、全面管理实验室的日常工作,合理安排及协调好日常测试任务;
7、熟悉实验室测试仪器和装置,对实验结果进行分析,解释;
8、熟悉专业领域内各类测试标准、产品标准,熟悉各类样品处理方法和测试分析方法,开发新测试方法;
9、对实验室人员进行有效管理,并协调好各部门间的关系,使工作顺畅进行;对实验室人员的技术水平提高进行培训和考核;
任职要求:
1、本科以上,机电、暖通或相近专业;环境工程、化学分析类相关专业
2、具备相关专业产品评价3年以上工作经验;
3、熟练操作电脑、OFFICE、AutoCAD等绘图软件;
4、有家电行业工作经验者优先考虑;
5、了解第三方测试;
有CNAS实验室认证经验,有环境、空气净化产品测试经验者优先。
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