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         

• 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。
• 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。
• 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 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。
• QA batch release as authorized qualification person by Qualified Person when need.(Including FP product, prefilled product and incoming material)                       

 在需要时作为被授权的QA执行产品批次放行,包括成品，预填充组装后的产品，原辅料等。

• Review and approve operational documents requiring QA approval in FP and Prefilled area (Prefill QC part), including but not limited to:           

 审核并批准所负责区域（成品包装，预填充组装及预填充组装QC部分），所有需要QA批准的文件，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

Deviation  偏差（DV）

Customer complain  客户投诉（CC）

Change requests  变更 (CR)

Quality activity plans 质量活动计划（QAP）

FMS Alarm follow-up form FMS 报警跟踪表

• logbook review 日志

Qualifications

• 4-yr (BS) Degree in Pharmaceuticals, Engineering or related field                                  
• Experience in Pharmaceutical industry is preferable.     最好具备制药行业相关的经验。
• Ability to worked effectively in cross- organizational networks                                                能够高效的跨部门合作
• Ability to influence department/process performance   具备影响负责部门/流程能力

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

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.