QA Engineer III

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

• The QA engineer responsible for all quality assurance related matters for responsible area in NN Site Tianjin, ensuring compliance with NMPA(National Medical Products Administration), EU GMP and NN internal procedures requirements. Assist line manager to make right decision from quality point of view.

质量保证工程师负责诺和诺德天津工厂负责部门的所有质量保证相关的事务，以保证所有生产活动和工作流程符合国家药品监督管理局和欧盟GMP的要求和诺和诺德内部流程要求。从质量的角度协助直线经理做出正确的决策。

• The below tasks are primarily related to STJ Fill/Finish Expansion (FFEx) project but may be extended to other QA responsible areas when line management judges the position-holder has necessary knowledge and experience. 以下工作主要与FFEx 项目相关，但经直线经理评估该职位负责人具备必要的知识和经验也可以扩展到其他部门。
• Support Quality management system establishment, maintenance and improvement, ensure high compliance with Novo Nordisk procedures and regulatory requirements.
• 支持建立，维护并改善质量管理体系，以保证其高度符合诺和诺德规程要求和法规要求
• Act as coordinator for the project to ensure global document being reviewed and implemented locally at FFEx STJ timely and correctly.                                                                                        协调总部文件本地化，确保总部文件被正确解读并及时准确地在FFEx天津项目执行。
• Coordinate to share other site finding to the project and drive relevant processes make evaluation and mitigation actions if it is necessary.
• 协调其他工厂审计发现项及时分享到项目，并推动项目相关职能部门进行分析，如有必要采取行动规避风险
• 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。
• Provide training to employees within and outside of the quality assurance department.                      向质量部内部和外部的员工提供培训。
• Handle and answer internal and external (authority) audits and regulatory affair inquiries.                   应对内、外部审计和检查，回答法规事务询问。
• Perform QA oversight for responsible area and handling relevant issues.                                    在自己负责领域内做质量保证监察并处理相关问题。
• 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。
• Provide quality management system related training to employees timely.                                   及时向员工提供质量体系相关培训。
• 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)
• logbook 日志
• Review and approve related Qualification/validation documents
• 审核和批准相关验证文件。

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
• Fluent in written and spoken English

良好的英语书写和沟通能力

• Minimum 3 years of experience in quality assurance, and/or working in a similar position.  至少3 年质量保证相关岗位工作经验。
• Have knowledge with cGMP requirements. Previous experience with quality system, quality assurance, ISO9000, cGMP，EMA and FDA quality system regulation.                                             具有cGMP要求的知识和相关经验。熟悉质量体系、质量保证、ISO9000, cGMP法规EMA和FDA质量系统法规。
• Broad experience with quality systems and standards applied by Novo Nordisk.                               熟悉诺和诺德质量体系和质量标准。                
• 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 delivered high quality results and demonstrated ability to improve processes.                           具有改进工作流程、高质量完成工作的能力。

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.