職位描述：

職責描述：

Responsibility

Controlofallqualitymanagementsystemdocumentationandinternal/externalengineeringspecifications,BOMandDrawings,including

·FormatcontrolandmaintainofQMSdocuments

·UploadingQMSdocumentstointranet,releaseanddistributionprocessfollowup

·Controlofengineeringspecifications,BOMandDrawings

·ReleaseandmaintainBOMinformationinERPsystem

SupporttheQualitySystemManagerintheimprovementofprocesses

Assureimplementationofcorporatepartnumberstandards

Collectandadministratetechnicalstandards,e.g.GBandDINstandards

Supportininternalaudit

Supportinmonthlynon-financialKPIdatacollection

Otherassistanttasksassignedbymanager

職位要求：

Qualifications

·Bachelordegreeorequivalentcombinationofeducationandexperience

·ProficientinbothwrittenandspokenEnglish

·ProficiencyinMicrosoftofficesoftware

·Majorinengineeringisaplus

·Strongorganizationalskillsandabilitytoreview/updateprocesses/procedures

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。