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Microbiologist

ID:112566861 分享到微信

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  • 五险一金
  • 补充医疗保险
  • 免费班车
  • 员工旅游
  • 专业培训
  • 通讯补贴
  • 交通补贴
  • 年终奖金
  • 定期体检
职位信息
  • 启动日期:2019-04-23
  • 招聘部门:其他
  • 汇报对象:无
  • 下属人数:无
  • 职位描述:
  • 主要工作职责Main responsibilities:

    ? 建立微生物实验室,包括设备和实验室相关操作流程;Setup the quality control program from product pilot to serial production lots

    ? 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;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.)

    ? 执行实验室所有设备的验证,日常运作监测和维护;Execute the qualification/ validation, routine monitoring and maintenance for lab equipment

    ? 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;Conduct the routine monitoring for sterilization vendor, liaise with serialization vendor to carry out the product sterilization and sterilization process validation

    ? 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;Establish quality specification, SOP, and working instruction, according to good laboratory practice (GLP), along with respect to corporate and local quality requirement

    ? 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

    ? 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); Conduct the final Product release and routine product quality sampling test (Bio-burden test, sterility test, LAL test, ETO residual test, etc.)

    ? 建立和执行洁净室产品系统放行机制; Establish& carry out the cleanroom product system release system.

    ? 调查质量的相关异常处理、变更实施和产品投诉调查;Conduct the related quality deviations handling, change controls and complaint investigation.

    ? 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; Assist related departments (such as the production department) to finish related validation activities, ensure the effectiveness and suitability of the validation activities;

    ? 微生物实验室仪器设备的校验与维护Calibration and maintenance management for lab equipment.

    ? 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;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.

    ? 执行安全操作和维持良好的安全的工作环境;Maintain and ensure safe working conditions

    知识/技能/工作经验Required Knowledge/Skills/Experience:

    ? 本科毕业、微生物,生化,制药或食品等理工科专业Bachelor degree, majored in science of Microbiology, Biochemistry, pharmaceutical, food etc.

    ? 至少3年以上的微生物实验室经历, 有3年以上欧美企业工作经验优先Minimum of 3 years working experience in microbiological laboratory, above 3 years in EU/US company is preferred

    ? 有食品,奶制品或制药行业工作经验优先Food, dairy or pharmaceutical experience is preferred

    ? 在医疗行业GMP环境下2年工作经验优先At least 2 years working experience in GMP environment of medical industry is preferred

    ? 英语说写沟通流利Good English communication both in oral and written.

    ? 熟悉ISO9001, GMP, GLP和验证操作Familiar with ISO9001, GMP, GLP and validation.

    ? 熟悉微生物实验室的质量控制流程Be familiar with micro lab internal quality controls

    ? 熟悉基本的实验室统计学工具,如SPC, MSA, GR&R等Familiar with quality control statistic tools, SPC, MSA, GR&R etc.

    ? 良好的办公室软件应用水平Good computer and software skills.

    个人特质/Personal qualities:

    ? 善于自我激励,积极主动,抗压力强Self-motivated, initiative and able to work under pressure.

    ? 良好的系统性思维和逻辑性强 Great Systematic& Logical thinking

    ? 优秀的团队合作者,沟通者和协调者Team work spirit. Good communication and coordination skills.


职位要求
  • 年龄要求:不限

    工作年限:3-4年

  • 学历要求:本科及以上

    专业要求:药学/生物医学工程

  • 是否统招:统招

    语言要求:英语

企业介绍

Saving lives is – without question – the greatest job in the world. Everything we do from architectural planning to the equipment, therapies and solutions aim to secure the safest and most reliable care. As a partner for integrated medtech solution Getinge provides innovations for operating rooms, intensive-care units, sterilization departments and for life science companies and institutions. Based on first-hand experience and close partnerships, we help to improve every-day life for people, today and tomorrow.

Founded in 1904 with roots going back to 1838, Getinge has grown both organically and through acquisitions to become a global market leader in many segments. In total, Getinge has over 15,500 employees in more than 40 countries. Our production is conducted at facilities in Brazil, Dominican Republic, France, Canada, China, Germany, Poland, Sweden, Turkey, the UK and the US.
We mainly covered in 3 business areas around the world :
1.Acute Care Therapies, offers pioneering technologies and solutions for intensive-care units, operating rooms and cardiology departments. This offering also includes equipment for treating patients while in transport.
2.Surgical Workflows provides solutions for infection control, operating rooms, advanced IT systems for traceability and management of the flow of sterile equipment as well as for optimal use of resources. This also includes products and services within the Life Science segment.
3.Patient & Post-Acute Care’s offering encompasses products and solutions for safe patient handling, prevention of venous thromboembolisms, medical beds, hygiene systems and early mobility, among others.

Getinge's cultural core values are; Passion – Collaboration – Openness – Excellence and Ownership.

MAQUET (Suzhou) Co., Ltd was established in April of 2007. As the only production bases outside Europe, MAQUET (Suzhou) upholds the concept of quality enhancement and high efficiency all the time. It belongs to the Getinge Group and has under it 2 Specialty divisions for Surgical Workplaces, Acute Care Therapies. We supply the global market with series of best-quality products.

We attach great importance to the employees self growth and development, valuing the diversity of individuals, ideas and what they bring to the workplace. At MAQUET, with favourable working and personal development environment, we offer all of the employees with large range of career opportunity and better training (domestic or overseas training) opportunities).

At Getinge, we believe in our people. We provide career opportunities that both inspire and challenge.
Want to join the team? Have a look at our available positions.

Please kindly visit more information about us at :www.getinge.com

迈柯唯医疗设备(苏州)有限公司

  • 外资(欧美)
  • 150-500人
  • 制药/医疗 | 机械仪表
  • 苏州市工业园区方洲路158号 地图