制药-验证经理 Validation Manager社
15K-20K/月
大连市
发布时间:2023-09-06
职位描述
职位描述:
工作职责:
RoleDescription
Thesuccessfulcandidatewillprovidestrategicandtacticalsupporttothemanagersandprofessionalsinallofthefollowingareas:currentGMPs,RegulatoryCMC,deviationinvestigations,lotrelease,regulatoryaudits,changemanagement,andcontemporaryproductandprocessvalidation.Willenablequalitystrategyanddrivechangestosupportmanufacturingproducttransfersassociatedwiththesite.Thecandidatewillalsomaintainappropriatecontactstoaccessadditionalinformationinregardstotheoverallpharmaceuticalcompliancelandscape.WillassurethatvalidationproceduresandpracticesarealignedwithPfizerQualityStandards(PQS).Thispositionleadsateamofmanagersandindividualcontributordirectreportswithawiderangeofqualitycomplianceresponsibilitieswithinvalidationandchangemanagement.
Responsibilities
Theresponsibilitiesincludebutarenotlimitedto:
TechTransfer:Supporteveryproductandtransferprojectatthesite.Theseprojectsarisefrommanyseparateprocesses,includingcontinuousimprovementprojects,andbusiness.Theincumbentwilldevelopclosecommunicationchannelswitheachofthesevariousprojectsources.
ProductandProcessValidation:SupportallproductandprocessvalidationandequipmentqualificationatthesitewhilefollowingindustrycontemporaryandPfizerQualityStandards.DevelopandmaintainaSiteValidationMasterPlanandaPeriodicReviewprogram.
AuditsandInspections:OrganizeandleadthesupportofregulatoryandinternalauditsastheyrelatetoValidationandChangeManagementProgram.SMEforvalidationrelatedtopicsduringregulatoryinspections,developresponsestopotentialfindings,andassuretimelycompletionofcorrectiveactionsandcommitments.
SiteChangeManagementProgram:Responsibletokeepallfinishedproducts,equipment,processesandfacilitiesincompliancewithcontemporaryindustrystandardsandregulatoryfilings.Reviewandapproveallproposedchangesimpactingfinishedproducts,equipment,processesandfacilities.
CleaningValidation:Ensurethatallcleaningprocessesarequalified,andthoseproductsprocessesofbeingenhancedarevalidatedappropriately.DevelopandmaintainaCleaningValidationMasterPlan.
EquipmentQualification:SupportallproductandprocessvalidationandequipmentqualificationatthesitewhilefollowingindustrycontemporaryandPfizerQualityStandards.DevelopandmaintainaSiteValidationMasterPlanandaPeriodicReviewprogram.
Thispositionisresponsibletomaintainthestructuretoensurethatallinternalandregulatorycommitmentsandtimelinesaretrackedandmet.Inaddition,resourceprojectionsandbudgetpreparationsareexpected.Alsoresponsibletoprovideoroverseethepreparationofprojectcostestimates,andwillprovidesupportandGMPreviewformajorsitecapitalprojects.
Responsibleforthedevelopment,mentoring,andperformancemanagementofateam,professionals,andtechnicians.Fosteringaculturewhereinnovation,scienceandrisk-basedqualityandcolleagueengagementthrive,framedwithinthePfizerValues
任职资格:
Qualifications
EducationandExperience:
BSMSorPhDinChemistry,Biochemistry,Microbiology,Engineering,Pharmacyorrelatedscienceandminimumof10yearsofrelatedexperience.Previousexperienceasamanagerofcolleaguesisrequiredandexperienceleadingfirstlinesupervisorsandmanagersarepreferred.
Thecandidateshouldhaveexperienceinatleastseveralofthefollowing:cGMPs,Regulatory(worldwide),deviationinvestigation,drugproductlotrelease,GMPAuditsupport,technicalproducttransfers,changecontrolmanagement,equipmentqualification,cleaningvalidation,computerizedsystemsvalidation,andproductandprocessvalidation.
TechnicalSkills:
Arobustworkingcomprehensionofthetheoryandfunctionofpharmaceuticalequipmentandsystemsisrequired.Thesemayincludesterilizers,depryrogenationovens,washers,WFI,HVACsystems,asepticfillingequipment,incubatorsrefrigerators,cleaningequipment,inspectionequipment,assemblyequipment,labelingpackagingequipment,datarecordersandpersonalcomputers.Knowledgeofcontemporaryvalidationguidelinesforpharmaceuticalindustry.
Abilitytoread,analyzeandinterpretcommonscientificandtechnicaljournals,financialreports(asneeded),andlegaldocuments;comprehendequipmentmanualsandtranslateoperationallimitsintoprotocolsacceptancecriteria;respondtoregulatoryagencies;andrespondtocomplaintsfromcustomers.
Abilitytodefineproblems,collectdata,establishfacts,anddrawvalidconclusion;interpretanextensivevarietyoftechnicalinstructionsinmathematicalordiagramformanddealwithseveralabstractorconcretevariables.Abilitytogatherandanalyzeinformationskillfullyandpresentinmanyforms.
Shouldhavetheabilitytoperformadvancedmathematicalconceptssuchasexponents,logarithms,quadraticequations(asneeded),andapplymathematicaloperationstosuchtaskssuchasfrequencydistribution,CpK,determinationoftestreliability.
Thecandidatemusthaveexcellentverbalandwrittencommunicationskills,withtheabilitytosharevision,direction,anddatawithcolleaguesacrossalllevelsandinawiderangeofdifferentworkgroups.
Thecandidatemusthavedemonstratedproficiencyinorganizationalandprojectmanagementskillsandmustbeabletobalancemultiplepriorities.
Toperformthisjobsuccessfully,anindividualshouldhaveanadvancedknowledgeofMicrosoftOffice(Word,Excel,Outlook,Access,andProjects).
WrittenCommunication
Writesclearlyandinformatively,strongtechnicalwritingskillsareessential;presentsnumericaldataeffectively.
OralWrittenCommunication
Listenscarefullyandgetsclarification;abletoexpresscomplexideasinaclear,concisemanner;capableofexplainingtechnicalissuestonon-technicalpersonnel.Writesclearlyandinformatively.
DeliverResults
*DemonstratesBusinessAcumen
*ActsDecisively
*SeizesAccountability
Individualcommitmentsandbusinessunitgoalsarealignedtostrategy,prioritizedtobusinessimpactasdefinedbyclearmeasuresofsuccess.Colleaguesareinspiredandfocusedonoutcomesandresultsthatachieveourorganization'spurpose.Performancestandardsandmetricsareinplace,commonlyunderstoodandreinforced.
EngageToday'sTalent&BuildtheNextGeneration
*HoldsPeopleAccountable
*BuildsEffectiveTeams
*Self-Awareness
*GrowsOthers
Colleaguesunderstandtheyareaccountableforoutcomesandareempoweredtodeliveruponcommitments.Theyrecognizethebusinessbenefitsofdiversityandinclusion,andthisenvironmentisopenlyfostered.Colleaguesbelongtoadiverseteam,capableofperformance,developingforfuturebusinessneedsandengagedtodotheirbestwork.Talentisidentifiedanddeveloped,mappedtofuturebusinessneeds,withpeoplesupportedintheircareersandbuildingnetworksacrossthebusiness.
ShapeTheFuture
*Commitsto”OnePfizer”
*LeadsChange
IndividualmusthaveathoroughunderstandingofcurrentindustryregulatoryandPfizerrequirementsinthisfieldaswellasindustrytrends.Colleaguesandteamarediverse,adaptableinthefaceofchange,havetheabilitytoidentifyopportunitiesandthedesiretocapitalizeonthem.ThePfizervaluesunderpineverydecisionandaction.Stakeholdersareappropriatelyinvolvedindecisionsthataffectthem.Climateisatangiblesubsetoforganizationalculturewheremanagershaveakeyroleinshapingandtransforming.
PHYSICALMENTALREQUIREMENTS
Whileperformingthedutiesofthisjob,theemployeeisoccasionallyexposedtogenerallaboratoryandormanufacturingareas;worknearmovingmechanicalparts;toxicorcausticchemicals;thenoiselevelintheworkenvironmentisusuallymoderate;requiredtostand;walk;sit;talkorhear;mustoccasionallyliftandormoveupto25pounds;specificvisionabilitiesrequiredbythisjobincludeabilitytoadjustfocus.
Musthavetheabilitytosimultaneouslymulti-taskacrossmultiplecapabilitiesandfunctionsandhandlemultiplecompetingprioritiesandrequirements,includingperformingsiteandfunctionalresponsibilities,respondingtofrequente-mailandphonecommunicationsandattendingmultiplemeetingsandconferencecalls.Notethattheseactivitiesmaynotbetimeboundtocorehoursorpresenceatthesite
其他要求
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1人
- 生物工程
公司介绍
大连工厂是辉瑞制药有限公司在大连开发区的生产基地,也是辉瑞全球生产集团(PGM)在中国的一个区域性供应组织。工厂占地面积82,000平方米,其中厂房设施占地20,586平方米。大连工厂拥有世界上最先进的生产设施和检测技术。产品包括多种片剂、粉针剂、粉剂和胶囊等多种剂型的制剂药。工厂率先于1997年4月获得国家GMP认证委员会颁发的中华人民共和国第0001号GMP认证证书,其综合生产能力已居国内领先水平。由于工厂拥有世界一流的检测分析手段和辉瑞全球统一的完善的质量保障体系,使工厂的产品全部达到或者超过了中国药典和美国药典标准。此外,大连工厂的产品还分别于1994年、1997年、2000年和2002年通过了澳大利亚TGA检验,已获准出口日本、澳大利亚、菲律宾、巴基斯坦及欧洲等地。并于2004年4月获得由德国莱茵认证公司颁发的ISO14001环境管理体系认证证书,同时获得了中国国家认证机构认可委员会的认可。
作为辉瑞全球生产集团的一部分,大连工厂一直致力于生产高质量的创新药品,百分之百地满足客户的需求。同时,不断改进和创新,努力降低生产成本,创造并保持其在本行业内最优异的环保、健康和安全方面的业绩。