QA崗位詳細要求

精選優(yōu)質(zhì)文檔-----傾情為你奉上精選優(yōu)質(zhì)文檔-----傾情為你奉上專心---專注---專業(yè)專心---專注---專業(yè)精選優(yōu)質(zhì)文檔-----傾情為你奉上專心---專注---專業(yè)InternationalQualityImplementationOfficerDetailedrequirements:Atleast2yearsofexperienceinpharmaceuticalqualityassurance.ThecandidatecanbecomingfromaQA/QCdepartmentorfromaproductiondepartmentifspecificqualityrelatedresponsibilityhasbeenpartoftheformerjob.Thecandidatecanbecomingfromananalytical,research,orotherinstituteforpharmaceuticalindustryifspecificqualityrelatedresponsibilityhasbeenpartoftheformerjob.GoodknowledgeofpharmaceuticalGMP(Chineseandinternational).ThecandidateshouldhaveknowledgeofGMPrelatedguidelinessuchasICH,PIC/S,WHO,EMA,FDA,etc.ThecandidateshouldknowthespecificdifferencesbetweeninternationalandChineseguidelines.Thecandidateshouldbefamiliarwithqualitysystemssuchasqualityoverview,riskmanagement,validationmanagement,deviationmanagement,changemanagement,etc.Thecandidateknowstheprocessesoflaboratoryequipmentqualificationandvalidationofanalyticalmethods.ThecandidateshouldbefamiliarwithgoodpracticessuchasGMP,GDP,GLP,etc.ThecandidatehasGMPknowledgeinconstructionprojects.ThecandidatehasknowledgeofAPIand/orFPPprocessesThecandidateunderstandsthatqualityisinordertoensurepatient’ssafety(andnotbecauseofauthorities).ThecandidateisabletolearninthefieldofquickchangingGMPenvironment.Organizationalskills.Thecandidateisabletoorganizetheownworkinordertomeettimelinesandgoals.Thecandidateisabletoorganizetheworkofcustomersinordertomeettimelinesandgoals.Thecandidatecandefinemilestonesfortheownworkandfortheworkofthesuppliersinordertomeetagreedgoalsandtimelines.ThecandidatehastheabilitytorealizeobstaclesandtocommunicatethemasearlyaspossibleCommunicativeandopenmindedaswellasgoodatteamworkThecandidateisabletocommunicateallkindsoftopicswhoeverthecounterpartis.Thecandidatecancommunicatetrulyandcomprehensivelyevenitisaboutdifficultissues.Thecandidatehasaprofessionalwaytocommunicategoalsandmilesstones.Thecandidateisabletocommunicateinafriendlybutdecisiveandconvincingway.Thecandidateisableandopentoseealternativewaystosolveproblemsorissues.Thecandidateisabletoacceptandrespectotherpersons’opinionsandcandiscussbasedonfacts.Thecandidateisreadytoshareideasandmakedecisionsbasedonfactsandreasonablediscussionsincludingallpersons’anddepartments’inputs.Thecandidateisabletoprovidenewideasforimprovementandcandevelopinnovativethinkingindependentonexistingsystemsanddefinitions.Thecandidateisabletomotivatecustomersandtakestheinitiativetopushworkprogressandpersons.Honestyhastobeabasicfeatureofthecandidate’scharacterAbilityofstricttimelinessofworkcompletionisamust.Thecandidateisabletoadherestrictlytotimelines.ThecandidateisabletoadjusttheworkincaseofobstaclesinordertomeettimelinesThecandidateisabletoinfluencethecustomer’sworkinordertomeettimelines.Thecandidatecommunicatesobstaclesasearlyaspossibleiftimelinescannotbemet.Abilityofin-depthanalysisofsystemsandproceduresisrequired.Thecandidatehastheabilitytodivedeepintosystemsorproblemsinordertounderstandcompletelytheverybasicfacts.Thecandidateisabletothinkinanabstractiveandanalyticalway.Thecandidatedoesnotstopaninvestigationoranalysisuntilthebasisisfound.Thecandidateisabletodepictcomplicatedissueinasimplified,understandablebutstillcorrectway.Thecandidateissatisfiedbypersistentquestioningandresearchingforrealcausesandbasicfacts.Abilitytoworkunderpressureisrequired.Thecandidatecanprovidethesamequalityofworkandbehavioreventhepressureishigh.Thecandidatecanwithstandstrongresistanceofcustomersandcanensurequalitystandards.Thecandidateisreadytoworkovertimeduringhighpressureperiodsinordertomeetgoalsandtimelines.Abilitytoworkaccordingtostandards,SOPs,anddefined/commonprocedures.Thecandidateisabletoadheretodefinedinternalprocessesandguidelines(eventheymaybearenotsuitableorreasonable).Thecandidateisabletorecordtrueinformation.Thecandidatecanseedifferencesbetweendefinedprocessesandbehaviororworkofhim/herselforothersandmakeproposalforadjustmentsifnecessary.Thecandidateunderstandshowtohandlenon-suitableornon-reasonableprocedures(e.g.bychangemanagement).SpokenandwrittenEnglishandChineseisamust.WrittenEnglishhastobeonahighlevel.OralEnglishcanbeonalowerlevel,buthastobeimprovedlater.國際質(zhì)量管理專員崗位詳細要求：兩年以上藥企QA工作經(jīng)驗如果之前崗位有部分職責(zé)是具體的質(zhì)量管理，則候選人員可以是來自QA/QC或生產(chǎn)部如果之前崗位有部分職責(zé)是具體的質(zhì)量管理，候選人可以是來自制藥行業(yè)的某分析測試機構(gòu)、研發(fā)機構(gòu)或其他機構(gòu)豐富的GMP知識（國內(nèi)及國外）候選人應(yīng)熟悉國際協(xié)調(diào)委員會、國際藥品稽查公約組織、世界衛(wèi)生組織、歐洲藥品管理局、美國食品藥品管理局等GMP指南候選人應(yīng)熟悉國際GMP和中國GMP指南的具體區(qū)別候選人應(yīng)熟悉質(zhì)量管理體系，如：質(zhì)量回顧概述、風(fēng)險管理、驗證/確認管理、偏差管理、變更控制等候選人應(yīng)熟悉實驗室分析檢測設(shè)備的確認和分析方法的驗證候選人應(yīng)熟悉相關(guān)的良好規(guī)范，如：優(yōu)良生產(chǎn)質(zhì)量管理規(guī)范、優(yōu)良文件管理規(guī)范、優(yōu)良實驗室管理規(guī)范等。候選人應(yīng)熟悉新建/擴建/改造項目相關(guān)的GMP知識候選人應(yīng)熟悉原料藥和/或制劑產(chǎn)品的生產(chǎn)工藝過程候選人應(yīng)具有很強的質(zhì)量觀念，即確保患者的安全（而不是為了應(yīng)付官方機構(gòu)的檢查）候選人對快速發(fā)展的GMP應(yīng)具有很強的學(xué)習(xí)能力良好的組織能力候選人應(yīng)能夠合理安排自己的工作并確保按期完成工作目標候選人應(yīng)能夠合理安排客戶（外部客戶：官方機構(gòu)、合作方等；內(nèi)部客戶：如生產(chǎn)、工程、銷售等）方面的工作，以確保按期完成工作目標候選人能夠確定自己和客戶方（解釋如上所述）工作的里程碑，已確保按期完成工作目標候選人應(yīng)能發(fā)現(xiàn)潛在障礙并盡早跟相關(guān)方進行溝通和協(xié)調(diào)良好的溝通能力并且思維活躍，良好的團隊合作能力候選人應(yīng)具備跟任何相關(guān)方就所有話題溝通協(xié)調(diào)的能力候選人應(yīng)具備就棘手事宜坦誠且全面深入溝通的能力候選人應(yīng)具備就目標和里程碑以專業(yè)的方式進行溝通協(xié)調(diào)的能力候選人應(yīng)具備以友好但堅決且有說服力的方式進行溝通協(xié)調(diào)的能力候選人應(yīng)具備用多種方法解決問題的能力候選人應(yīng)能夠接受并尊重別人的觀點，并能夠以事實為依據(jù)進行討論候選人應(yīng)具備分享觀點且基于事實做決定和合理討論所有人員以及各部門改進的信息候選人應(yīng)能夠基于現(xiàn)有系統(tǒng)和情形獨立提出新的改進建議以及具有創(chuàng)新思維的能力候選人應(yīng)能夠帶動客戶（定義如上所述）并能夠積極主動的推進工作和帶動他人誠實守信是候選人必備的基本素