Microbiology Professional IV

Category:  Quality
Location: 

Tianjin, Tianjin, CN

   

Education Background: 教育背景

 

  • 4-yr (BS) Degree in Microbiology, Pharmacy, or related field.              微生物学、药学或其他相关领域学科4 年本科教育学士学位
  • Good communication skill and culture understanding
  • 良好的沟通能力和文化认可
  • Good at English, both verbal and written
  • 良好英文口语及写作能力

 

Professional Experience专业经验:

 

  • Minimum 3 years of experience in a microbiological laboratory experience,  preferably in a pharmaceutical or GMP lab setting 至少3年微生物实验室经验,制药或GMP实验室背景优先
  • Experienced in using aseptic technic and performing OOS investigations 有无菌操作及超标结果调查经验
  • Experience with pharmacopoeia methods for water/product analysis such as TFS/TVC/LAL/Microbiological ID tests and environmental monitoring analysis (USP/EP/JP/CP) 有水及产品的药典(美国/欧洲/日本/中国药典)分析方法经验,例如,无菌检查/微生物限度测试/内毒素测试/微生物鉴定及环境监控
  • Proficient and skilled in using computers and software, including word processing and spreadsheet programs 精通和熟练使用电脑及软件,包括文本处理和电子数据表程序
  • Previous experience in using an electronic laboratory data management system (LIMS) desirable 有使用实验室电子数据管理系统(LIMS)的经验
  • Previous experience in working according to technical documents in English desirable有根据英文专业技术文件工作的经验

 

 

The Microbiology Professional will work as part of a team responsible performing quality control testing of insulin products, in process solution, raw materials, excipients and water for pharmaceutical use. In doing so, the Microbiology Professional will be responsible for activities related to operating a wide variety of laboratory equipment, including Isolator, Microseq, LAL, Autoclave, Microscope, Air sampler, Particle Counter etc. The Microbiology Professional will also be responsible for implementing methods of analysis previously established at other NN sites and set up methods according to pharmacopeias. 作为微生物实验室的一部分,微生物专员负责胰岛素产品,中间品溶液,原辅料和制药用水的质量控制。因此,微生物专员将负责大量实验室仪器的操作,包括隔离器,基因测序仪,酶标仪,灭菌锅,显微镜,空气采样器,粒子计数器等。微生物专员还将负责执行已在其他NN工厂建立的分析方法和按照药典建立方法。

 

  • Perform analysis on samples and report/review results timely 进行样品分析并及时报告/复核结果
  • Set up methods of analysis and execute method transfer studies 建立分析方法并进行方法转移研究
  • Head and document laboratory investigation as LI supervisor role 作为实验室调查主导者,主导和记录实验室调查
  • Perform problem solving related to testing of insulin products, excipients and water for pharmaceutical use on reruns, deviations etc. in QC Microbiology Dept. and support cross Dept. problem solving 解决在质量控制微生物实验室发生的与胰岛素产品,辅料及制药用水检测相关的再测试,偏差等问题并支持跨部门的问题解决
  • Write methods of analysis and other operational documents. Translate key operational documents from English into Chinese. 书写分析方法和其它操作文件,翻译关键英文操作文件成中文
  • Train other end users to operate equipment and to execute methods of analysis 培训仪器操作的其他最终用户并执行分析方法
  • Prepare for the audit and inspection and to be a auditee to answer the questions and be the the finding owner to investigate and close the finding. 准备内外审计并作为被审员回答问题,并且也作为发现项的负责人,调查和关闭发现项
  • Perform and document all work in accordance with GMP, site, and corporate procedures and policies 按照GMP,工厂和集团程序和政策执行和记录所有工作
  • Maintain a safe working environment and work in compliance with all NN and local Chinese safety and environmental regulations 维护安全工作环境并按照所有NN和中国安全和环境的要求工作

 

Other individual assignments 其他 :

  • Develop and maintain competencies to perform routine testing, training, validation and CR handling 发展和维护日常检测,培训, 验证和CR处理的能力
  • Incorporate Novo Nordisk Way (NNW) into daily way of working 运用诺和诺德之道于日常工作中
  • Travel abroad to other NN sites for training or meetings if needed 如果需要,去其它工厂参加培训和会议
  • Keep line manager accurately informed of work status as well as any problems 正确无误通知直线经理工作状态和任何问题
  • Implement systems and standards to ensure best practices and standardization with other DFP sites within processes, equipment, systems wherever possible 运用系统或标准以确保最优方法及与其他DFP工厂在工艺,仪器,系统等任何可能的方面的标准化
  • Be familiar with Chinese GMPs and regulatory requirements related to testing methods and laboratory 熟悉与测试方法和实验室相关的中国GMP和法规要求
  • Use cLean and PS@Shopfloor principles in problem-solving and other daily work 解决问题和日常工作中使用cLean PS@Shopfloor 原则

 

  • Perform the tasks assigned by manager.执行经理安排的任务

 

 

 

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.