QA崗位詳細要求

精選優(yōu)質文檔-----傾情為你奉上精選優(yōu)質文檔-----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.國際質量管理專員崗位詳細要求：兩年以上藥企QA工作經驗如果之前崗位有部分職責是具體的質量管理，則候選人員可以是來自QA/QC或生產部如果之前崗位有部分職責是具體的質量管理，候選人可以是來自制藥行業(yè)的某分析測試機構、研發(fā)機構或其他機構豐富的GMP知識（國內及國外）候選人應熟悉國際協(xié)調委員會、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指南候選人應熟悉國際GMP和中國GMP指南的具體區(qū)別候選人應熟悉質量管理體系，如：質量回顧概述、風險管理、驗證/確認管理、偏差管理、變更控制等候選人應熟悉實驗室分析檢測設備的確認和分析方法的驗證候選人應熟悉相關的良好規(guī)范，如：優(yōu)良生產質量管理規(guī)范、優(yōu)良文件管理規(guī)范、優(yōu)良實驗室管理規(guī)范等。候選人應熟悉新建/擴建/改造項目相關的GMP知識候選人應熟悉原料藥和/或制劑產品的生產工藝過程候選人應具有很強的質量觀念，即確?；颊叩陌踩ǘ皇菫榱藨豆俜綑C構的檢查）候選人對快速發(fā)展的GMP應具有很強的學習能力良好的組織能力候選人應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能夠合理安排客戶（外部客戶：官方機構、合作方等；內部客戶：如生產、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能發(fā)現潛在障礙并盡早跟相關方進行溝通和協(xié)調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具備跟任何相關方就所有話題溝通協(xié)調的能力候選人應具備就棘手事宜坦誠且全面深入溝通的能力候選人應具備就目標和里程碑以專業(yè)的方式進行溝通協(xié)調的能力候選人應具備以友好但堅決且有說服力的方式進行溝通協(xié)調的能力候選人應具備用多種方法解決問題的能力候選人應能夠接受并尊重別人的觀點，并能夠以事實為依據進行討論候選人應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能夠基于現有系統(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