Senior QA Engineer-filling

Category:  Quality

Tianjin, Tianjin, CN


Purpose of the Job 职位目标:


The senior QA engineer is responsible for all quality assurance related matters for Wash & Sterilization department in NN Site Tianjin, ensuring high compliance with GMP requirements. 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.



Main Job Tasks 岗位职责:       

  • 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QA监察并处理相关问题。
  • Establish SOPs for quality related processes and procedures where relevant.
  • 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 affairs inquiries.                 应对内、外部审计,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
    • Batch production record BPR)  批记录文件
    • Non-conformities   偏差
    • Internal complain and customer complain  内部投诉和客户投诉
    • Change requests CR 变更  
    • Quality activity plans 质量活动计划(QAP
    • Preventative maintenance plan  预防维修计划
    • Calibration specification sheets  校准说明书
    • Logbook  日志

Annual product review (APR)  年度产品回顾


Other individual assignments 其他 :

  • Incorporate Novo Nordisk Way (NNW) into daily way of working                                             将诺和诺德之道(NNW)融入到日常工作中
  • Other work assigned by line manager.                                                                      直线经理安排的其他工作。
  • Keep line manager accurately informed of work status as well as any problems                             保证将工作状态和所有问题准确通知到直线经理
  • Perform role of process responsible in regard to quality and compliance when assigned by line manager.     当直线经理指定时,担任质量和合规的流程负责人。

Keep Ready for travel both domestic and overseas at any time according to business needs.                  能够根据业务需要随时到国内外出差


Education Background: 教育背景


  • 4-yr (BS) Degree or above in Pharmaceuticals,

engineering or related field

药学,工程学其他相关领域学科4 年本科教育学士或以上学位

  • Fluent in written and spoken English



Professional Experience专业经验:


  • Minimum 5 years of experience in Pharmaceutical industry including production or quality assurance position.                   


1~3 years’ experience and knowledge in quality assurance or aseptic processing related area are preferred.


  • Good knowledge on regulatory requirements and expectations from NMPA and EU.                     


  • Ability to worked effectively in cross- organizational networks                                                能够高效的跨部门合作
  • Ability to influence department/process performance 


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.