QC Support Professional II

Category:  Quality
Location: 

Tianjin, Tianjin, CN

   

Qualifications (minimum requirements) 任职资格
Education Background: 教育背景

•    4-yr (BS) Degree in Microbiology, Chemistry, Pharmacy, or related field.                   微生物学、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 3 years of pharmaceutical Lab experience with laboratory equipment maintenance, calibration, qualification and troubleshooting
至少3 年制药厂实验室仪器设备维护、验证、校验和问题解决的经验
•    Previous experience with project management is desirable                                                具有项目管理的经验
•    Knowledge in GMP and Pharmacopoeia requirements related to Lab.
熟知实验室相关的GMP和药典的要求
•    Good presentation and coordination skill
良好的讲解和协调能力
•    Previous experience with international pharmaceutical company desirable
具有国际制药公司的工作经验

Job content工作内容描述
Purpose of the Job 职位目标: 

The QC support professional is responsible for 4 aspects as below. 
质量控制支持专员有以下4个方面的职责:
1.    Ensure all tasks and activities in QC comply with NN standards and Quality Management System, including NC/CR handling, SOP writing and training, stability study, process SME, etc. 
负责NC/CR处理、SOP编写和培训、稳定性研究,过程专家,以保证质量控制所有任务和活动符合诺和诺德标准和质量管理体系要求。
2.    Ensure all equipment needed to operate in QC Lab are procured, installed, qualified, operated and maintained in accordance with the production plan and timeline.  
负责按照生产计划和时限采购、安装、验证、使用和维护质量控制实验室的仪器和设备。
3.    Ensure the department’s environmental, health and safety work is compliance with the requirements of NN policies and other relevant regulations. 
确保部门的环境、健康和安全工作符合诺和诺德相关政策和其他相关法规的要求。
4.    Project management for laboratory projects.
负责实验室项目的项目管理。
Main Job Tasks 岗位职责:       
•    QC laboratory equipment responsible. Procure, install, qualify, calibrate, and maintain all types of QC laboratory equipment. Write specifications, protocols and reports for qualification of laboratory equipment. Develop and implement ongoing qualification, calibration and maintenance programs in QC. Write equipment instructions and train end users to operate equipment.                                 
QC实验室设备负责人。采购、安装、验证和维护质量实验室各类仪器设备。编写实验室仪器的标准、验证的方案和报告。开发和执行QC持续性验证、校验和维护程序。编写设备规程并培训最终用户如何操作设备。
•    Use systematic problem solving tools to handle non-conformities.                                           用系统的解决工具去完成实验室的不符合报告。
•    Lead and drive continuous improvement for QC process and handle change request in related to change.    推动QC流程持续改进,并对相关变更撰写CR。
•    Perform the stability test for insulin products produced in PS Site Tianjin. Ensure samples are pulled, tested and results are reported within required time frames.                                                       执行诺和诺德天津工厂生产的胰岛素产品的稳定性实验, 确保稳定性样品被在要求的时间范围内及时取出并检测及结果及时汇报。
•    Project responsible for QC area projects. Develop project plan, direct project execution, monitor project progress and report project performance. 
QC部门项目负责人。制定项目计划、指导项目执行、跟进项目进展以及汇报项目成果等。
•    Maintain a safe working environment and work in compliance with all NN and local Chinese safety and environmental regulations
维护安全的工作环境并且按照所有诺和诺德和中国当地安全和环境法规工作。
•    Support on quality compliance related tasks, including compliance gap analysis, close audit/inspection finding, audit readiness, etc.
支持质量合规相关工作,包括合规差距分析,关闭审计/检查的不符合项,审计准备等。
Other individual assignments 其他 :
•    Other work assigned by line manager                                                                       直线经理安排的其他工作
•    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
•    Special role and responsibility, e.g.:  SME (subject matter expert), EHS representative, etc.
个人承担的特殊职责, 如:SME,EHS代表,等等        
•    Be familiar with Chinese GMPs and regulatory requirements related to laboratory
熟悉实验室相关的中国GMP和相关法规要求                   
 

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.