Qualifications (minimum requirements) 任职资格：

Education Background: 教育背景：

Minimum 4-yr (BS) Degree in Microbiology, Biology, Chemistry, Pharmacy, or related field.

微生物学、生物学、化学、药学或其他相关领域学科4年本科教育学士学位

Fluent in written and spoken English

良好的英语书写和沟通能力

Professional Experience专业经验:

Minimum 7 years of pharmaceutical Lab experience with test operation

至少7年制药厂实验室的实验操作经验

Previous experience with project management is desirable

具有项目管理的经验

Previous experience with pharmacopoeia microbiology methods for water/product analysis (USP/Ph.Eur./JP/Ch.P.) 具有药典关于水/产品的微生物分析方法的经验（方法包括美国/欧洲/日本/中国药典）

Job content工作内容描述：

Purpose of the Job 职位目标:

Insulin QC Senior Professional works as a team member of insulin QC team. He/she will have a thorough knowledge of the key analytical process in the department. The daily work includes overall work of method validation, difficult CR handling, OOS investigation, SOP writing and training, implement methods of analysis previously established at other NN sites, etc.

Moreover, Insulin QC Senior Professional is responsible for setting up and managing QC Lab test process for Novo Nordisk insulin products produced in PS Site Tianjin and serve as a method owner.

胰岛素质量控制高级专员作为胰岛素实验室团队的成员，需要对部门内分析规程的关键点有全面的了解并能融会贯通。日常工作包括方法验证全套工作、复杂CR处理、OOS调查、SOP编写和培训、推行已在其他诺和诺德生产厂建立的分析方法等。

并且，胰岛素质量控制高级专员还负责建立及管理诺和诺德天津工厂生产的胰岛素产品的实验的流程，担任方法负责人。

Main Job Tasks 岗位职责:

Thorough overview of key analytical processes。

关键分析过程的全面概观

Perform systematic problem solving related to testing of insulin products use on reruns, non-conformities.

使用再运行、不符合等方式系统地解决实验室在胰岛素产品相关实验的问题。

As the pharmacopeia responsible for microbiology part, identify gaps between pharmacopeia and NN lab process, ensure compliance for local process and analytical method, clarify pharmacopeia understanding, foresee new Ch.P. according to USP/Ph. Eur. trend, and send efficient/related comment/suggestion to Authority. 作为微生物部分的药典负责人，识别诺和诺德实验室现有流程和药典之间的不同，确保本地流程及分析方法的符合性，澄清药典的理解，依照美国药典/欧洲药典的趋势，对新版中国药典进行前瞻，对***提出有效/相关的评论/建议。

Drive project management related to ｄｅｌivery, improvement and compliance etc, drive local signal.

主导与供货、简化、合规相关的项目管理与本地signal。

Be familiar with Chinese GMPs and regulatory requirements related to testing methods and laboratory.

熟悉测试方法和实验室相关的中国GMP和法规要求。

Leading to perform the method validation and Pharmacopeia comparison

可以带领及主导实验室进行方法验证和药典对比。

Perform and document all work in accordance with GMP, site, and corporate procedures and policies. Write SOP、methods of analysis and other operational documents, translate key operational documents from English into Chinese.

所有操作和记录文件符合GMP、工厂和公司流程政策。编写SOP、分析方法和其他操作文件，将关键操作文件的英文版本翻译成中文。

Setting up and managing QC Lab test process for Novo Nordisk insulin products produced in PS Site Tianjin and serve as a method owner.

建立及管理诺和诺德天津工厂生产的胰岛素产品的实验的流程，担任方法负责人。

Be the responsible for laboratory method transfer, method validation or method verification.

作为实验室方法转移、方法验证或方法确认的负责人。

Train other end users to operate equipment and to ｅｘｅｃute methods of analysis, and perform matured PC for sustainable compliance and improvement.

培训其他最终用户如何操作设备和进行实验，并能成熟的执行PC以确保持续的合规及优化。

Other individual assignments 其他 :

Ready for travel at any time according to business needs

能够根据业务需要随时出差

Keep line manager accurately informed of work status as well as any problems

保证将工作状态和所有问题准确通知到直线经理

Be familiar with Chinese GMPs and regulatory requirements related to testing methods and laboratory

熟悉关于测试方法和实验室的中国GMP和相关法规要求

As LI supervisor, head LIs in QCC, ensure scientific investigation and effective actions.

作为实验室调查主导人，主导实验室调查，确保调查充分、行动有效

Other work assigned by line manager

直线经理安排的其他工作

Special role and responsibility, e.g.: SME (subject matter expert), PR (process responsible), etc.

个人承担的特殊职责， 如：SME，PR等等

专业要求：不限