QA Engineer III

2 months ago

Tianjin, China Novo Nordisk Full time

   

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             

1. 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。

2. Perform QA presence 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。

3. 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。

4. Provide training to employees within and outside of the quality assurance department.                      向员工提供质量相关培训。

5. 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。

6. QA batch release as authorized qualification person by Qualified Person when need.                         在需要时作为被授权的QA执行产品批次放行。

7. 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
  • Batch production record （BPR）   批生产记录
  • Non-conformities  偏差（NC）
  • Customer complain and internal complain  客户投诉和内部投诉（CC and IC）
  • Change requests  变更 (CR)
  • Quality activity plans 质量活动计划（QAP）
  • Preventative maintenance plans 预防维修计划（PMP）
  • Calibration specification sheets  校准说明书
  • Alarm follow-up form 报警跟踪表
  • Annual product review (APR)  年度产品回顾
  • logbook 日志

 

Qualifications

1. 4-yr (BS) Degree in Pharmaceuticals, Engineering or related field   药学、工程学或其他相关领域学

4 年本科教育学士学位

2. Fluent in written and spoken English良好的英语书写和沟通能力

3. 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。

4. Good knowledge on regulatory requirements and expectations from SFDA and EU.                         熟悉国家食品药品监督管理总局和欧盟法规要求。

5. Ability to work effectively in cross-organizational networks

能够高效的跨部门合作

6. Ability to influence department/process performance

具备影响负责部门/流程能力

 

 

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.

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.

 

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