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
- 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.
- Good presentation and coordination skill
- Previous experience with international pharmaceutical company desirable
Purpose of the Job 职位目标:
The QC support professional is responsible for 4 aspects as below.
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.
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.
3. Ensure the department’s environmental, health and safety work is compliance with the requirements of NN policies and other relevant regulations.
4. Project management for laboratory projects.
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.
- 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.
- Maintain a safe working environment and work in compliance with all NN and local Chinese safety and environmental regulations
- Support on quality compliance related tasks, including compliance gap analysis, close audit/inspection finding, audit readiness, etc.
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.
- Be familiar with Chinese GMPs and regulatory requirements related to laboratory
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.