崗位職責(zé):
崗位職責(zé)概述:
本職位領(lǐng)導(dǎo)團(tuán)隊(duì),負(fù)責(zé)維護(hù)與優(yōu)化生產(chǎn)部門多個(gè)基地的GMP合規(guī)體系,協(xié)助生產(chǎn)管理團(tuán)隊(duì)確保所有
生產(chǎn)活動(dòng)、文件及人員狀態(tài)符合cGMP及公司質(zhì)量要求。核心職責(zé)涵蓋文檔體系、審計(jì)、偏差變更
及培訓(xùn)管理,以保障生產(chǎn)運(yùn)營的持續(xù)合規(guī)性。
Thispositionisresponsibleforleadingtheteamtoestablish,maintain,andoptimize
theGMPcompliancesystemwithintheManufacturingDepartment.Thecoremissionistoensure
allproductionactivities,documentation,andpersonnelstatuscomplywithcGMPandcompany
qualityrequirements,coveringdocumentmanagement,audits,deviations/changecontrol,
andtrainingtoguaranteeongoingcompliance.
崗位具體職責(zé):
?監(jiān)督生產(chǎn)部門GMP文件體系的全生命周期管理,包括SOP、MBR、logbook及培訓(xùn)材料等文件的
創(chuàng)建、審核與更新流程;負(fù)責(zé)相關(guān)文件的批準(zhǔn),并推動(dòng)多個(gè)生產(chǎn)基地GMP文件體系的標(biāo)準(zhǔn)化與
持續(xù)改進(jìn),確保執(zhí)行同一套高標(biāo)準(zhǔn)、可審計(jì)的質(zhì)量規(guī)范。
Overseethelife?cyclemanagementoftheGMPdocumentsystemwithinProduction,
includingprocessesforcreating,reviewingandupdatingdocumentssuchasSOPs,MBRs,
logbooks,andtrainingmaterials;approverelevantdocumentsanddrivestandardization
andcontinuousimprovementofGMPdocumentsystemacrossproductionsitestoensure
adherencetothesamesetofhigh?standard,auditablequalitystandards.
?主導(dǎo)生產(chǎn)部門的內(nèi)外部GMP審計(jì)迎檢工作,擔(dān)任主要協(xié)調(diào)人,并領(lǐng)導(dǎo)團(tuán)隊(duì)對(duì)審計(jì)發(fā)現(xiàn)項(xiàng)進(jìn)行根
本原因分析,確保糾正與預(yù)防措施(CAPA)的有效執(zhí)行與按時(shí)關(guān)閉。
LeadthepreparationforinternalandexternalGMPauditswithintheproduction
department,actingastheprimarycoordinator,andguidetheteaminrootcauseanalysis
forauditfindingstoensureeffectiveandtimelyclosureofCAPAs.
?監(jiān)督生產(chǎn)過程中的偏差與變更控制流程,確保偏差及時(shí)調(diào)查與批準(zhǔn),跟蹤其落地執(zhí)行情況;建
立與GMP合規(guī)直接相關(guān)的KPI,并制定相應(yīng)的監(jiān)控與定期回顧機(jī)制。
Supervisethedeviationandchangecontrolprocessesinproduction,ensuring
deviationsarepromptlyandthoroughlyinvestigatedandapproved,andtrackingtheir
effectiveimplementation;establishGMP?relatedKPIsanddevelopcorresponding
monitoringandperiodicreviewmechanisms.
?領(lǐng)導(dǎo)GMP合規(guī)團(tuán)隊(duì)的日常運(yùn)作與發(fā)展,負(fù)責(zé)工作分配、績效管理及能力建設(shè),并在生產(chǎn)部門內(nèi)
倡導(dǎo)和推廣持續(xù)改進(jìn)的質(zhì)量文化。
LeadthedailyoperationsanddevelopmentoftheGMPcomplianceteam,includingtask
assignment,performancemanagement,andcapabilitybuilding,whilepromotingaculture
ofcontinuousimprovementandqualitywithintheproductiondepartment.
任職要求:
任職要求
?本科及以上學(xué)歷,生物、藥學(xué)、化學(xué)、制藥工程或相關(guān)專業(yè)。
Bachelor'sdegreeoraboveinPharmacy,PharmaceuticalEngineering,Chemistryora
relatedfield.
?至少5年以上制藥行業(yè)生產(chǎn)、質(zhì)量保證(QA)或質(zhì)量控制(QC)相關(guān)經(jīng)驗(yàn)。
Minimumof5yearsofexperienceinpharmaceuticalproduction,QA,orQC.
?精通cGMP、藥品管理法及相關(guān)行業(yè)指南,深刻理解藥品生產(chǎn)質(zhì)量管理的全過程。
ProficientincGMP,theDrugAdministrationLaw,andrelevantindustryguidelines,
withadeepunderstandingoftheentirepharmaceuticalproductionqualitymanagement
process.
?具備出色的文檔管理能力、審計(jì)迎檢經(jīng)驗(yàn)及偏差/變更處理經(jīng)驗(yàn)。
Strongdocumentmanagementskills,andsubstantialexperienceinaudit
hosting/handling,aswellasdeviationandchangecontrolprocesses.
?優(yōu)秀的溝通、協(xié)調(diào)和團(tuán)隊(duì)領(lǐng)導(dǎo)能力,能夠有效地與生產(chǎn)、質(zhì)量及其他部門協(xié)作。
Excellentcommunication,coordination,andteamleadershipskills,withtheability
tocollaborateeffectivelywithProduction,Quality,andotherdepartments.
?具備優(yōu)秀的英文書面和口語溝通能力,能夠熟練撰寫和審核英文技術(shù)文件,并作為接口人與外
部審計(jì)官進(jìn)行有效交流。
StrongwrittenandverbalcommunicationskillsinEnglish,withtheabilityto
proficientlydraftandreviewtechnicaldocumentsinEnglishandserveasaninterface
foreffectivecommunicationwithexternalauditors.