職位描述
ComplianceAssociateManger質量監督副經理
YourResponsibilities:
Yourresponsibilitiesinclude,butnotlimitedto:
MaintainQualification/ValidationSystemofBNP.MonitorthestatusofQualification/Validationandensureequipment/utilityandcontrolinstrumentforGMPactivitiesarevalidated/qualified.ReviewandchecktheQualification/Validationdocumentationforcorrectness,completenessaccordingtobothtechnicalandGMPspecificrequirement.
維護工廠確認/驗證系統。監測其確認/驗證狀態以確保設備/設施和相應儀器儀表符合GMP要求。復核并檢查確認/驗證文件的正確性，確保從技術層面和GMP完全符合指定要求。
Assuranceoflocalconcept/guidelinesforproductrelatedprocessvalidationandconfirmation,cleaningvalidation,transportationvalidation,deviation/investigationduringprocessvalidation/confirmation,cleaningvalidationandtransportationvalidationarealignedwithregulatoryrequirementandNovartisrequirements.
確保產品相關的工藝驗證和確認，清潔驗證，運輸驗證相關的觀念及指導，工藝驗證/確認，清潔驗證及運輸驗證相關的偏差/調查符合法規要求及諾華要求.
Participateinestablishment,implementationandmaintenanceofthequalitysystem,oversighteffectivenessofprocessvalidation,cleaningvalidationandtransportationvalidationrelatedsitequalitysystems.
參與質量體系的建立、執行和維護，監督工廠工藝驗證，清潔驗證及運輸驗證相關的質量系統的有效性；
Providecompliancesupportwithcommentsduringprocessvalidation/confirmation,cleaningvalidation,transportationvalidationprotocolandreportpreparationandreview.
在工藝驗證/確認、清潔驗證驗證及運輸驗證方案及報告的準備和審閱過程中提供合規指導；
Providecompliancesupportforinvestigation/deviationhandlingforprocessvalidation,cleaningvalidationandtransportationvalidationinvolvesomeprocessimprovementprojecthappenedinBNP.
為工藝驗證、清潔驗證和運輸驗證的調查及偏差處理提供合規支持，參與BNP工藝改進項目。
DesirableRequirements:
LifeSciencebachelordegreeorabove.(Pharmacist,ChemistorequivalentscientificEducation),LocallanguageandEnglishfluentinspeaking/writing
生命科學本科以上相關學歷；（藥學、化學或相關科學專業教育），對于母語和英語具有流利的表達能力和較強的寫作能力
Min.5years’experienceofmanagementofproductionandquality,includingexperienceinin-processcontrolandqualitycontrol.
具有至少五年從事藥品生產和質量管理的實踐經驗，包括從事過藥品生產過程控制和質量檢驗工作
WhyconsiderNovartis?
927million.That’showmanylivesourproductstouchedin2017.Andwhilewe’reproudofthatfact,inthisworldofdigitalandtechnologicaltransformation,wemustalsoaskourselvesthis:howcanwecontinuetoimproveandextendevenmorepeople’slives?
Webelievetheanswersarefoundwhencurious,courageousandcollaborativepeoplelikeyouarebroughttogetherinaninspiringenvironment.Whereyou’regivenopportunitiestoexplorethepowerofdigitalanddata.Whereyou’reempoweredtoriskfailurebytakingsmartrisks,andwhereyou’resurroundedbypeoplewhoshareyourdeterminationtotackletheworld’stoughestmedicalchallenges.
Joinusandhelpusreimaginemedicine.
