QA Engineer III
Tianjin, Tianjin, CN
Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment. Apply now and join Novo Nordisk. Together we can create life-changing innovation. Together we can make it happen.
The position
IT& automation QA engineer has the responsibility and the authority to: 高级IT与自动化QA工程师被授权负责以下工作:
- Document approval and Quality Oversight on IT functional and non-functional qualification for facility and equipment, especially in production line introduction projects, including: 仪器设备和设施,尤其是产线引入项目中,相关IT功能性和非功能性验证的文件的批准和质量巡检,
- Document approval and Quality Oversight on IT operation and maintenance, including but not limited to: IT运维相关的文件批准和质量巡检,包括但不限于:
- Coordinate and/or support the actions necessary to achieve planned results and continual improvement of Quality Management System. 协调并支持必要的活动以达到预期的结果,推动质量管理体系的持续改进。
- Handle and answer internal and external (authority) audits and regulatory affair inquiries. 应对内、外部审计和检查,回答法规事务调查和询问。
- Drive and develop business intelligence & office automation, especially implementation of office digitalization solutions in Quality Area. 在质量区域引领和开发商业智能和办公自动化,确保办公数字化解决方案的落地。
- Carry out other Quality, Business, Projects related tasks assigned by the Quality VP or Site Management. 执行工厂管理层及质量副总裁指派的其他质量、业务、项目等相关任务。
Qualifications
- 4-yr (BS) Degree in Pharmaceuticals, Engineering or related field
药学、工程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
- Minimum 3 years of experience in IT, automation or CSV related positions, experience in pharmaceutical industry and quality assurance preferred, experience related to CSV preferred
至少3年IT或自动化相关职位工作经验,制药行业和质量保证工作经验优先, 计算机化系统验证工作经验优先
- Good knowledge on regulatory requirements and expectations of cGMP from NMPA and EU especially for IT和automation related part.
Working at Novo Nordisk
At Novo Nordisk we recognise 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 the communities we operate in.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.
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.