QA Engineer IV

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，包含:
  • URS and Validation Planning  URS和验证计划
  • IT Risk Assessment IT风险评估
  • FAT & SAT
  • IQ, OQ and PQ
• 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：
  • Standard operating procedure (SOP)  标准操作规程
  • Change requests and IT changes 变更(CR)和IT变更
  • IT incident  IT事件
  • IT Periodical System Evaluation  IT 系统阶段性回顾
  • IT Recovery Plan 备份恢复计划
• 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.                            

熟悉国家食品药品监督管理总局和欧盟法规要求,尤其是IT和自动化相关的部分。

• Previous work experience on driving and developing business Intelligence & office automation, especially office digitalization solutions preferred

最好有引领和开发商业智能和办公自动化，尤其是办公数字化解决方案的工作经验

• Familiar with application of Tableau, RPA, Power Platform, etc.

熟练使用Tableau，机器人流程自动化RPA，低代码开发平台Power Platform等

• Self-motivated, self-learning and innovation mindset     具备较强的内驱力,自我学习能力和变革创新意识
• Ability to worked effectively in cross- organizational networks.                                              具有在跨组织的工作网络中高效工作的能力。
• Has demonstrated ability to deliver high quality results and improve process.                                   具有改进工作流程、高质量完成工作的能力。
• Good communication skill and be able to convince internal stakeholders on disagreements.                 具备良好的沟通能力，当有不同意见能够说服相关方以达成一致

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.