職位描述：

職責描述：

Summary

?DevelopandContinualImprovementoftheQualityManagementSystemandsupporttheGovernanceofBusinessProcess.

?Ensureexecutionofproperinternalauditstoallcorporatefunctionsformeasuringcompany’scompliancetotheQualitySystemasrequiredbytherelevantISO/VDAStandards.

?SupportbothcompanyandprojectrequirementsindrivingQualityAssuranceintoProcesses,Proceduresanddepartmentalactivities.

DutiesandResponsibilities

(thesearethepositionsessentialdutiesandisnotanall-inclusivelist)

Mainareasofresponsibilitiesare:

?EnsureaproperQualityManagementSystembasedontheGlobaloneisinplaceandcontrolledincompliancewithISO/VDArelevantstandards.

?ParticipateinthedevelopmentoftheQualityManagementSystembasedonBusinessProcessesandtheircontinuousimprovement.

?CoordinatelocalcertificationswithCertificationBodiesandmanageexternalaudits.

?EnsurecompliancetoQualityManagementSystemandrelatedISO/VDAStandardsbyestablishingandperforminginternalauditsthatmeasuretheeffectivenessoftheSystems;includingmanagementoflocalandcross-Countryauditplans.

?EnsurethatQualityManagementSystemdocumentationisupdatedaccordingtoguidelines.

?EnsureeffectiveexecutionoftheProcessesMilestones(QAMM)throughouttheProjectfromKick-offtoClose-out.

?SupportQMOManagerintheimplementationofcommonQualitymethodologies,toolsandinformationsystems,theircontinuousimprovementandalignmentonbestpractices.

?SupportQMOManagerinthemonitoringofQualityKPIs,theanalysisofresultsandthedevelopmentandmonitoringofimprovementplans.

?AssureLessonsLearnedandNonconformityprocessarefacilitatedanddrivenbackintotheBusinessProcessesforcontinuousimprovement.

?ResponsibletoidentifyandcommunicateQualitygeneralconcernsandorissuestoappropriatedepartment.

?Supportcontinuousimprovementactivitiese.g.,Kaizen,5S,SixSigmaprojects,valueengineering,leanmanufacturing,etc.

Knowledge&Skills

?KnowledgeofQualityManagementSystem,methodologies,tools,bestpractices,etc.

?KnowledgeofISO/VDAStandardsprincipleswithinthescopeofapplication.

?ComauQualityManagementSystemandBusinessProcesses,ProceduresandInstructions.

?ISO9001/VDA6.4internalauditorcertification.

?UnderstandingofgeneralCorporateoperationsandbusiness(multipleBUexperienceisaplus).

?Qualityphilosophies–Basicprinciplesandpractices

?ManagementSystemsstandards

?ComauQualityFoundations

?QualityKPI(KeyPerformanceIndicators)

?Quality-specificITtools

?ManagementSystemAuditingSkills

?SupplierAuditingSkills

?GeneralknowledgeofWCMQC-Pillar

?ProblemSolving:Defectanalysisandprevention,

?ReliabilityandRiskManagement

?Customerspecifications(TechnicalandRegulatory)

?OutlineofProductDevelopmentProcess/MilestonesandQualityGatesmanagement

?Chargeback

BehavioralCompetencies

?Teamworkwithcrossfunctionalteams

?Communicationskills,verbal,writtenandfollow-up

?Abilitytointerfaceinamulticulturalenvironment.

?Businessawareness

?Managingrelationships

?Communication

?Personalorganization

?Changeminded&driven

?

Qualifications

?Education:

oBachelordegreeinEngineeringrequiredandorganizationandindustryexperience.

?Previousexperiences

oAminimumof3yearsinQualityAssuranceorProcessQualityManagementexperienceintheautomotiveoralliedindustry.

oExperiencesinEngineering/Manufacturingenvironmentpreferred.

?Languages

oEnglish:fluent

職位要求：

篇2:質量體系管理專員崗位職責任職要求

質量體系管理專員崗位職責

質量體系高級專員-供應商管理QSSr.Specialist諾化仕(無錫)制藥有限公司諾化仕(無錫)制藥有限公司,諾化仕JobResponsibilities:

1.Suppliermanagement:managementofsupplierrelatedSOPandWI;guideforthesupplierqualificationprocess;generateannualsupplierauditplanandreport;executeandorganizesupplieraudits;generatesupplierauditreports;follow-uptheCAPAactionswithsupplier;follow-upthestautsofsupplier;annualevaluationofsuppliers;keepandmaintencethesupplierlist;

2.QSmanagement:updateQSofGMPrelatedmaterialsandproducts;

3.Supportandparticipatetheself-inspectionofsite;

4.Follow-uptheinteraudit(corporate)actionsandreport;

5.Supplierdossiermanagement;

6.Othersuppliermanagementrelatedworksfromcorporate;

7.otherassignedworks.

JobRequirements:

1.ExperiencedwithsuppliermanagementinaGMPcondition;familiarwithGMPandISO9001,andrelatedstandards;

2.HavetheexperienceofGMPself-inspection;

3.Goodcommunicationandcoordinationability;

4.Goodlearningcapacity,canlearnNovacylproceduresmoothly;

5.Goodwithteamwork,executiveforce;

6.Canhandlepressurefromworkload;

7.Englishwritingandread;

8.Skillfulusingmicrosoftword,excel,PPT,Windows,etc;

9.BasicknowledgeaboutGMP,saftyandchemical.

質量體系管理專員崗位

篇3:質量體系專員職位描述與崗位職責任職要求

職位描述：

1.本科學歷：藥學、生物技術或生物工程等相關專業；

2.兩年以上醫藥/醫藥包裝/醫療器械行業質量體系管理經驗，參加過內審和外部審核；

3.熟悉ISO9001、ISO13485、CFDA、GMP質量管理體系，接受過ISO13485或ISO19001的培訓，具有內審員資格；

4.熟練使用各種辦公軟件，如：SAP,Word,Excel,Outlook;

5.能流利的閱讀和書寫英語；

6.文字表達能力強，能獨立建設、編寫、匯檔體系文件；

7.認真細致，良好的溝通能力和親和力，責任心強，有團隊協作精神，良好的職業操守和敬業精神。