QA Engineer

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             

• 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。
• Review and approve related Qualification/validation documents
• 审核和批准相关验证文件。
• 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 。
• 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：

1. Standard operating procedure (SOP)  标准操作规程
2. Validation deviations  验证 偏差 （ VDV ）
3. Change requests  变更 (CR)
4. Supplier related document （ e.g SQP ） 供应商相关文件（例如 供应商质量计划）
5. Preventative maintenance plans 预防维修计划（ PMP ）
6. Calibration specification sheets  校准说明书
7. logbook 日志

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。
• 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。
• Have knowledge with cGMP requirements.               具有 cGMP 要求的知识和相关经验。
• 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。
• Experience with QC lab operation, equipment and method validation

QC 实验室操作，设备 / 方法验证相关经验

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.