QA Auditor社

面议

市辖区本科及以上

发布时间：2023-09-06

职位描述

职位描述：

PositionTitle:QAAuditorReportsTo:GlobalQAAuditManagerJobSummary:Supportsandexecutestheoverallregulatory,internalcorporateandvendorauditprogramsincluding;auditscheduling,execution,reporting,follow-upandclosureofinternalcorporateandexternalsuppliersaudits.SupportsandcontributestotheCorporateQualityAuditfunctionasrequired.JobResponsibilities:1.InaccordancewithApotexSOPs,performcorporatequalityauditsofApotexsites,preparereportsandmeetwithsitequalityandotherdepartmentmanagementtoreviewauditfindingsand,asnecessary,assistintheinvestigationofauditfindingstodeterminerootcauseandcorrective/preventiveactions.Issueauditreport,performfollow-upandcloseoutcorporateaudits.2.CoordinateandschedulesupplierandserviceproviderauditsinaccordancewithApotexSOPsandcurrentGMPs.Conductsupplieraudits,issueauditreports,follow-uponresponsesCAPAsandcloseoutsupplieraudits.3.Developandmaintaineffectiverelationshipswithexternalsuppliers,contractors,andbusinesspartnersaswellasApotexSiteQAandotherinternaldepartmentsinordertoensuretimelyaudits,communication,andresolutionstodiscovereddeficienciesand/orconcerns.4.ProviderecommendationstoseniormanagementthathavedirectimpactonApotexsiteandsupplierqualityandsubsequentcommercialmanufacturingoperationsand/orproductsupply.5.Makesrecommendationsfortheauditsystem,workingwithdepartmentswithinandoutsideQAtoimprovequalityasrelatedtothesystem,producingreportsasrequired.ToensuretimelyinputofdataintotheAuditSystem.6.Providetechnicalandregulatoryguidancetointernalandexternalstakeholderstoensureoverallqualityandcompliance.7.Supportsmanagementtoensurethecontinuouscompliance,developmentandimprovementofApotexandvendorauditprograms.8.Provideinformationonregulatoryrequirementsandstayabreastofchangesinregulatoryenvironment/trends.9.Identifiesrootcauseofproblems-proposessolutionsandimplementsactionplanstomitigaterisks,informingandescalatingasrequired.10.ProvidelogisticssupportduringinspectionsofApotexsitesbyregulatoryagenciesandcustomers.Followupandcompileinformationtosupportresponseandcommitmentsmadeintheresponsetoinspectionreports.11.Prepare,updateandreviewproposedchangestoSOPs,asrequired.12.EnsurethatallworkisperformedinfullcompliancewithcurrentGoodManufacturingPractices,GoodLaboratoryPractices,GoodDistributionPractices,StandardOperatingProcedures,allregulatoryrequirements,andestablishedsafetystandards.13.Workindependentlyorinateam,eitherwithinQAorwithvariousdepartments,toensurethatallworkiscompletedinatimelyfashiontomeetbusinessneeds.14.ProvideQAsupporttootherdepartmentsasrequired.15.Performotherdutiesasrequired.JobRequirements:·Universitydegreeinscienceorscience-relatedfield·Minimum6yearsofrelevantexperienceintheGMPRegulatedindustry,3yearsofwhichhasbeenspentinQualityAssurance,preferablywithauditexperience·Extensiveknowledgeofcurrentgoodmanufacturingregulationsasapplicabletothepharmaceuticalindustrywithinregion.(e.g.,HealthCanada,FDA,EUandotherinternationalregulations)·HaveknowledgeandunderstandingoftheICHguidancedocuments·ClearandconcisewrittenandverbalEnglishcommunication·Goodcommunication,interpersonalandorganizationalskills·KnowledgeofWord,Excel,PowerpointandotherMicrosoftofficeprograms·Upto60%travelrequired

其他要求

招聘人数：1人
职能类别：QA工程师

公司介绍

奥贝泰克药物化学（天津）有限公司是加拿大ApotexInc.独资在中国建立的公司，是一个具有国际先进水平的医药原料药研发、中试和小批量生产中心。公司高度重视研发，相信技术是企业发展的推动力，愿为有志在制药行业发展的有机合成，化学工程，药物分析，药物化学，国际贸易等方面的人才提供展现你才能的舞台。
报名方式：
应聘职位人员请在信封上注明应聘职位并将中英文简历，各种能力证书复印件，身份证复印件，联系方式及近照一张寄至：
天津经济技术开发区海星街19号
奥贝泰克药物化学（天津）有限公司人力资源部
邮编：300457
E-mail：zhaopin@apotexpharmachemchina.com