QA assistant director社

20K-30K/月

市辖区本科及以上

发布时间：2023-09-06

职位描述

职位描述：

?PositionSummary：
Assessthecomplianceofstudieswithinternalandexternalstandardsandthefollowingglobalregulations:GoodLaboratoryPractice(GLP)regulations,GoodManufacturingPractice(GMP)regulations,USFoodandDrugAdministration(USFDA),ChineseFoodandDrugAdministration(CFDA),EuropeanMedicinesAgency(EMA),OECDPrinciples,andcompanySOPs.Conductinspections/auditsofdrugdiscovery,preclinical,clinicalandcommercialproductsafetyevaluationstudiesintendedforclientworldwideregulatorysubmissionsandmarketedproducts.ReportQAfindingstotestfacility/linemanagementandstudydirectors.Prepareandsignregulatorydocumentse.g.QAUStatements,GMPdocumentsasrelatedtotesting.ProvidethetimelyassessmentofcompliancetomeettargetdateswithinallGLPandGMPareas.Asnecessary,monitorcorrectiveactionandconductfollowupforcomplianceissues.
?InteractwithregulatoryagenciesduringGLPandGMPinspectionsandwithclientsduringvisits/auditsconductedatWuXiAppTec,SuzhouBiosafetyLabs.Conductregulatorytrainingprograms,i.e.,GLPtrainingandGMPTraining.ProvidefeedbackandguidancetoallGLPandGMPareasonregulatoryissues.Assessqualitymanagementsystemsinnon-regulatedareasasdirected.
?Review,auditandprovideadvice/inputintosystemsandprocessessupportingtheQualityAssuranceeffortwithinBiosafetyTestingLabsatSuzhousite.
?PlanandimplementtheQAmonitoringsystemsnecessarytoassureadherencetointernalstandardsandglobal/regulatorypracticesfordatasupportingclientworldwideregulatorysubmissions.Providetraining,writeandreviewQASOPs,conductsystem,processandvalidationaudits,manageQArecordsandevaluatecomplianceoffacilitieswithinSuzhousiteandvendors.
?ProvidesupervisiontointernalQAstaff;includingbutnotlimitedtotraining,developmentalneeds,performancereviews,andbudgetreviews.ScheduleQAprojectsasnecessaryandreviewandapproveQAreports.SignforQAmanagementreviewofprotocolsandreportsandassociatedamendmentsforChinesesubmission.SignforQAmanagementreviewoffacilitySOPs.


KEYRESPONSIBILITIES
?Conductinspections/auditsofstudies,facilities,processes,systemsandvendors,reportobservationstomanagement,bothtestfacitlityandlineandstudydirectors,andmaintaincompleteinspection/auditfilesonassignedstudies/projects
?Schedule/conductinspectionsofQAactivities
?Auditstudyprotocols,batchrecords,finalreportsandassociatedamendmentsandprepareQAUstatementsforfinalreportswithinallGLPareas
?Auditstudybatchrecords,finalreports,certificatesofanalysisandassociatedamendmentswithinallGMPareas
?InteractwithalllevelsofmanagementofallGLPandGMPareas
?Interactwithclientsduringvisits/audits
?AssistinthepreparationofQAaudittechniques,formsandchecklistsandprepareandreview/approveQASOPsandqualityprocesses
?Interactwithregulatoryauthoritiesduringinspections
?Provideadvice/consultationonQAandregulatoryissuesandqualitymanagementsystems
?Support/auditcomputervalidationprojectsandactivities
?ReviewChinese/EnglishtranslateddocumentationorSOPs
?ReviewSOPsforcompliancewithGLPandGMPregulations
?ConductinternalGLP/GMPQualitytrainingprograms
?MaintainQArecordsandMasterScheduleandimplementandsupportQAtrendanalysis
?ReviewandapproveQAdocumentsincludingbutnotlimitedtoauditreports,QAstatementsandQASOPs
?SignforQAManagementreviewofprotocolsandreportsandassociatedamendments,asnecessary,forChinesesubmission.
?ActasDeputyforDirectorofQAfortheBiosafetyTestingLabsfordesignatedresponsibilities


MINIMUMREQUIREMENTS
?DegreeinNaturalSciencesorcomparablerelatedexperience
?Atleast10yearsexperienceinproductdevelopment,includingauditing/inspectingagainstregulatorystandardsand/orworkinaGLP/GMPfacility
?Atleast3yearexperienceinmanagingpersonneleitherasdirectsupervisorordeputyfordepartmentalmanagement.
?Goodinterpersonalandcommunication(writtenandoral)skills
?GoodunderstandingbothwrittenandoralofEnglishlanguage
?Understandingofregulatory(GLP/GMP)requirements
?Abilitytocomprehendscientificandmathematicalterminologyandcalculations

其他要求

招聘人数：1人
职能类别：生物工程

公司介绍

上海药明生物技术有限公司是上海药明康德新药开发有限公司的全资子公司，由原来的生物制药和生物工艺部，生物新药发现部独立出来成立了一家专门做生物制药的公司，这两个部门于2011年成立，于2015-5-1号独立出来组建新公司，是全球领先的制药、生物技术以及医疗器械研发开放式能力和技术平台公司，在上海和无锡均有运营实体。作为一家以研究为首任，以客户为中心的公司，药明生物向全球制药公司、生物技术公司以及医疗器械公司提供一系列全方位的实验室研发、研究生产服务，服务范围贯穿从药物发现到推向市场的全过程。药明生物的服务旨在通过高性价比、高效率的研发服务帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。

公司官网：http://www.wuxiapptec.com.cn

地址：中国上海外高桥保税区富特中路288号
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邮政编码：200131