Microbiologist Engineer 苏州

月薪： 1-1.5万/月

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 免费班车
  • 员工旅游
  • 交通补贴
  • 餐饮补贴
  • 通讯补贴
  • 专业培训
  • 出国机会
  • 绩效奖金
  • 年终奖金

职位描述

职位描述： Title: Microbiologist EngineerReport to: Quality ManagerJob Summary:According GLP and cooperate quality requirement, setup effective and appropriate lab quality control program for critical system validation/routine monitoring, related product components incoming inspection, product sterilization and related testing program, from process setup to mass production, improve product quality performance through test, control, or process improvement.  负责从生产线初建到量产整个生产过程的生产环境验证及日常监测，负责相关原材料来料检验，产品灭菌及产品的相关检测项目等，根据GLP和总部质量系统的要求建立适当有效的实验操作流程，并通过测试、控制及改进流程以提升产品质量。Responsibilities/岗位职责:1.Setup the quality control program from product pilot to serial production lots  建立微生物实验室,包括设备和实验室相关操作流程2.Be knowledgeable about the plant equipment and environment for optimum performance in equipment and environmental cleaning. Liaise with production personnel to carry out the validation and routine monitoring for environment and critical systems (air system, water system, etc.)  熟悉工厂设施和洁净室环境的相关质量要求以求***的运行水平,主导完成生产洁净室环境和关键设施(如压缩空气,水系统等)验证和日常监测3.Execute the qualification/ validation, routine monitoring and maintenance for lab equipment  执行实验室所有设备的验证,日常运作监测和维护4.Conduct the routine monitoring for sterilization vendor, liaise with serialization vendor to carry out the product sterilization and sterilization process validation  执行灭菌供应商的日常管理,与灭菌供应商协作完成产品的灭菌及产品的灭菌工艺验证5.Establish quality specification, SOP, and working instruction, according good laboratory practice (GLP), along with respect to corporate and local quality requirement  根据GMP中的实验室规范（GLP）,以及总部和当地的质量相关要求，建立合适的实验室操作流程,SOP和工作指导书6.Establish GMP related SOP. Train and qualify the process inspector all quality control activities, immediately report all observations of GMP non-conformances during the routine monitoring  建立GMP活动相关SOP,培训和认证实验室质量检验人员的所有质量控制活动,及时汇报和处理日常工作中的异常状况7.Establish and conduct the incoming inspection for the related cleanroom product components, according Corporate quality requirement and relevant. ISO standard.  按照公司内部规范和相关ISO行业标准,建立并执行洁净室产品相关原材料和控制生产性物料的来料检测活动8.Conduct the final Product release and routine product quality sampling test (Bio-burden test, sterility test, LAL test, ETO residual test, etc.)  根据放行标准执行最终的产品放行监测和日常的产品抽样监测 （初始污染菌,无菌测试,细菌内毒素测试,环氧乙烷残留测试等）9.Establish& carry out the cleanroom product system release system. Conduct the related quality deviations handling, change controls and complaint investigation  建立和执行洁净室产品系统放行机制;调查质量的相关异常处理、变更实施和产品投诉调查10.Assist related departments (such as the production department) to finish related validation activities, ensure the effectiveness and suitability of the validation activities   协助相关部门（例如生产部）等完成相关的验证活动,确保验证活动的有效性和适宜性11.Maintain the preventive maintenance plan for relevant production/measurement equipment, liaise with relevant resource to conduct the preventive maintenance for that equipment according the main schedule   维护生产和检测设备的维护计划，并协调相关资源按计划完成校验活动12 Analysis the lab quality trend (Defect Rate, data trending, etc.) on an ongoing basis, improve the product quality performance level with implementation of continuous improvement tools   持续分析实验室检测质量趋势（如缺陷率，数据趋势等），并应用持续改进工具不断的提高产品的质量表现Requirements/岗位要求:1.Bachelor degree or above with Good English skill both in written and oral本科或以上学历，良好的英语读写能力2.Minimum of 3 years working experience in microbiological laboratory& in GMP environment of medical industry, Pharmaceutical experience至少3年以上医疗行业GMP环境下的微生物实验室经历，制药行业工作经验优先3.Be familiar with micro lab internal quality controls熟悉微生物实验室的质量控制流程4.Be familiar with GMP, ISO13485 and relative quality tools熟悉GMP, ISO13485和其他质量工具5.Good communication and team work skill良好的沟通能力和团队合作能力6.With responsible, and careful personality. Self-motivated, initiative and able to work under pressure细心，责任心强善于自我激励，积极主动，抗压力强 职能类别： 生物工程/生物制药 医疗器械生产/质量管理

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汇杰是一家专业国际招聘咨询服务公司，致力于为企业提供中高级专业人才的招聘解决方案。汇杰咨询在2004年创办于苏州，现在已经成长为中国长三角地区最专业的人才服务机构之一。 汇杰扎根于中高端人才的招募，专注于工业制造、能源化工、医药医疗、消费品、教育、现代服务业、通用职位等行业的招聘。 我们的招聘领域包含：高层管理、工程与运营、人力资源、信息技术、市场营销、供应链、财务等领域。每个岗位职能又可以按照行业细分到更深层次的不同职能。

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