QC驗證主管崗位職責

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驗證主管崗位

篇2:產品驗證主管崗位職責

實驗室主管+產品驗證美埃(中國)環境凈化有限公司中山美埃凈化技術有限公司,美埃職責描述:

1、新開發、改進產品的性能、可靠性的實驗驗證和評價;

2、針對售后問題進行產品、關鍵元器件市場投訴問題分析;

3、產品新引進風機、電路板等關鍵資材對整機系統的影響評估和實驗驗證;

4、協助及跟進完善整機整改流程;

5、根據市場及售后問題完善評價體系、標準制度、體系建設;1、新開發、改進產品的性能、可靠性的實驗驗證和評價;

6、全面管理實驗室的日常工作,合理安排及協調好日常測試任務;

7、熟悉實驗室測試儀器和裝置,對實驗結果進行分析,解釋;

8、熟悉專業領域內各類測試標準、產品標準,熟悉各類樣品處理方法和測試分析方法,開發新測試方法;

9、對實驗室人員進行有效管理,并協調好各部門間的關系,使工作順暢進行;對實驗室人員的技術水平提高進行培訓和考核;

任職要求:

1、本科以上,機電、暖通或相近專業;環境工程、化學分析類相關專業

2、具備相關專業產品評價3年以上工作經驗;

3、熟練操作電腦、OFFICE、AutoCAD等繪圖軟件;

4、有家電行業工作經驗者優先考慮;

5、了解第三方測試;

有CNAS實驗室認證經驗,有環境、空氣凈化產品測試經驗者優先。