天津招聘Microbiology Professional

Microbiology Professional

诺和诺德（中国）制药有限公司

公司规模：1000-5000人
公司性质：外资(欧美)
公司行业：制药/生物工程

职位信息

发布日期：2021-06-02
工作地点：天津-滨海新区
招聘人数：2人
工作经验：2年经验
学历要求：本科
职位月薪：0.8-1万/月
职位类别：质量管理/测试工程师(QA/QC工程师)

职位描述

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

Purpose of the Job 职位目标:

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

? As microbiological culture repsonsible person, will be responsible for the whole process related to microbiological culture, including purchase, turnover, collection, storage, confirmation testing, transfer, using and disposal, etc. 作为菌种负责人，将负责菌种的申购，进出，收集，贮藏，确认，转种，使用及销毁等全过程。

? 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 在解决问题和日常工作中使用cLean 和 PS@Shopfloor 的原则

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

职能类别：质量管理/测试工程师(QA/QC工程师)

关键字：生化分析实验英语听说读写数据分析统计

公司介绍

诺和诺德在中国
诺和诺德是中国市场的领导者，一直以改变为己任。诺和诺德（中国）制药有限公司于1994年成立，二十几年来业务一直保持强劲增长。公司总部设在北京，产品和服务遍及全国所有省、直辖市及中国港澳台地区。截至2017年底，诺和诺德在华员工总数4329人。诺和诺德是在中国建立研发中心的生物制药公司。位于北京的研发中心是诺和诺德全球研发体系的组成部分，致力于与总部合作研发新产品及新生产工艺。诺和诺德在中国的生产厂位于天津，是公司的国际化战略生产基地。公司对工厂提供了大量的资金投入和技术支持，向全球以及中国市场供应产品。诺和诺德在中国的不断发展反映了公司对中国市场的承诺。

Novo Nordisk in China
As the leader in the Chinese market, Novo Nordisk has always been committed to Changing.
Founded in 1994 and headquartered in Beijing, Novo Nordisk’s presence in China has been growing for more than 20 years.Headquartered in Beijing, providing products and services across mainland China as well as Hong Kong, Macau and Taiwan of China. As of the end of 2017, Novo Nordisk employed over 4,329 employees in China.

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