QC驗證主管崗位職責(zé)

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(chǎn)品驗證主管崗位職責(zé)

實驗室主管+產(chǎn)品驗證美埃(中國)環(huán)境凈化有限公司中山美埃凈化技術(shù)有限公司,美埃職責(zé)描述:

1、新開發(fā)、改進(jìn)產(chǎn)品的性能、可靠性的實驗驗證和評價;

2、針對售后問題進(jìn)行產(chǎn)品、關(guān)鍵元器件市場投訴問題分析;

3、產(chǎn)品新引進(jìn)風(fēng)機(jī)、電路板等關(guān)鍵資材對整機(jī)系統(tǒng)的影響評估和實驗驗證;

4、協(xié)助及跟進(jìn)完善整機(jī)整改流程;

5、根據(jù)市場及售后問題完善評價體系、標(biāo)準(zhǔn)制度、體系建設(shè);1、新開發(fā)、改進(jìn)產(chǎn)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(xié)調(diào)好日常測試任務(wù);

7、熟悉實驗室測試儀器和裝置,對實驗結(jié)果進(jìn)行分析,解釋;

8、熟悉專業(yè)領(lǐng)域內(nèi)各類測試標(biāo)準(zhǔn)、產(chǎn)品標(biāo)準(zhǔn),熟悉各類樣品處理方法和測試分析方法,開發(fā)新測試方法;

9、對實驗室人員進(jìn)行有效管理,并協(xié)調(diào)好各部門間的關(guān)系,使工作順暢進(jìn)行;對實驗室人員的技術(shù)水平提高進(jìn)行培訓(xùn)和考核;

任職要求:

1、本科以上,機(jī)電、暖通或相近專業(yè);環(huán)境工程、化學(xué)分析類相關(guān)專業(yè)

2、具備相關(guān)專業(yè)產(chǎn)品評價3年以上工作經(jīng)驗;

3、熟練操作電腦、OFFICE、AutoCAD等繪圖軟件;

4、有家電行業(yè)工作經(jīng)驗者優(yōu)先考慮;

5、了解第三方測試;

有CNAS實驗室認(rèn)證經(jīng)驗,有環(huán)境、空氣凈化產(chǎn)品測試經(jīng)驗者優(yōu)先。