QC验证主管岗位职责

QCValidation/QualificationSupervisor仪器验证主管诺化仕(无锡)制药有限公司诺化仕(无锡)制药有限公司,诺化仕,诺化仕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.