QA Engineer II

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       

Key areas of responsibility:         

Purpose of the Job 职位目标 :

The senior QA engineer of IT is responsible for all IT quality assurance related matters in department scope, ensuring high compliance with cGMP requirements and internal NN procedures. Assist manager to make right decision from quality point of view. Support other QA colleagues with technical knowledge. Support stakeholders when they consult about compliance questions.

The senior QA engineer of IT is responsible for driving and developing business intelligence & office automation, to fulfil the purpose of data based decision-making, FTE release, etc.

The overall success will be measured upon:

1. High efficiency/quality work of process support.
2. Independent capability of process support and problem solving.
3. Good behaviour for high quality mind set, simplicity the process and continuous improvement.

Good co-operation and communication with inside/outside department/site stakeholder with across boundary behaviour.

高级 IT 质量保证工程师负责部门业务范围的所有 IT 相关质量保证事务，以保证所有生产活动和工作流程高度符合 cGMP 的要求以及诺和诺德内部程序。从质量的角度协助经理做出正确的决策。向其他质量保证工作人员提供专业技术知识培训；向其他同事提供合规相关问题的咨询意见。

该高级 IT 质量保证工程师负责在质量区域引领和开发商业智能和办公自动化，以顺应趋势实现利用数据支持业务决策，释放重复劳动的劳动力等目的。

工作的成果从以下方面衡量：

1. 高质高效地完成流程支持工作
2. 独立地完成流程支持工作和解决问题
3. 高度的质量意识、良好的行为表现、简化流程以及持续改进

与各个工作相关方良好合作和进行有效沟通。

Main J ob T asks 岗位职责 :  

Sr. Validation & IT QA has the responsibility and the authority to:                                                   验证及 IT 高级质量保证工程师被授权负责以下工作：

Validation & IT QA coordinates and/or supports the actions necessary to achieve planned results and continual improvement of Quality Management System.                                                                      验证及 IT 系统质量保证工程师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。                        

Provide quality and compliance related input and make decisions on quality and compliance related issues. 对质量和合规相关问题给出建议和意见，并决定处理方法。

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。

1. Related Validation documents approval, including IT functional and non-functional qualification for facility and equipment                                                                                             相关验证文件的批准，包含仪器设备和设施的相关 IT 功能性和非功能性验证。
2. Establish SOPs for quality related processes and procedures where relevant
   建立质量相关流程和操作程序的 SOP 。
3. Provide training to employees within and outside of the quality assurance department.          

• 向员工提供质量相关培训。
• 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。
• Review and approve operational documents requiring QA approval, including but not limited to:             审核并批准所有需要 QA 批准的操作性文件，包括但不限于：
  • Standard operating procedure (SOP)  标准操作规程
  • Change requests  变更 (CR)
  • IT incident  IT 事件
  • IT Periodical System Evaluation  IT 系统阶段性回顾

Being the Site Core Process SME, responsible for:

• Act as One-point of entry for process related issues in the unit
• Ensure stable and effective execution of the process.
• Monitor compliance and operational performance within in the unit and provide knowledge on process performance e.g., product quality, operational performance, compliance performance and equipment/system performance.
• Explore and understand the ability, capacity and limitations of the process, equipment and supporting systems.
• Ensure that all unit SOPs within the process comply with QMS and are technically and practically workable.
• Participate actively in the Process Group work and participate in meetings as agreed.
• Ensure awareness in line management in relation to prioritization of Process Group activities, e.g., resource allocation for compliance- and improvement activities
• Verify readiness for audit and inspections and be ready for process presentations within own unit and process                                         

Qualifications

1. 4-yr (BS) Degree or above in IT, automation, Pharmaceuticals Engineering or related field      IT 、自动化、药学、 工程学或其他相关领域学科 4 年本科学士学位或以上
2. Fluent in written and spoken English

良好的英语书写和沟通能力

1. 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

1. 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。
2. 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

1. 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

1. 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
2. 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。
3. Good business understanding across and above site, and ability to integrate specialist knowledge and business perspective.                                   深入理解工厂内部和上游的业务，有能力将专业知识有效运用到业务中。
4. 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。

1. 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.

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.

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.