QA Engineer

Category:  Quality
Location: 

Tianjin, Tianjin, CN

   

Key areas of responsibility 主要工作职责:

This position is responsible for:

  • Quality assurance to ensure the compliance with GMP requirements and expectations from NMPA and EU guidelines and internal NN procedures.
  • Support other colleagues to guarantee compliance to GMP requirement from NMPA and EU guidelines and from internal NN procedures.
  • Assist line manager to make right decision from quality point of view.

 

Main Job Tasks 主要工作任务:     

  • Provide quality and compliance-related input and make decisions on quality and compliance-related issues
  • Perform QA presence and handling relevant issues
  • Perform logbook QA review
  • Review and approve operational documents requiring QA approval, including but not limited to:
    • Standard Operating Procedures (SOPs)
    • Deviations
    • Change request
    • Preventative Maintenance Plans
    • Calibration Specification Sheets
    • EM trend reports.
  • Identify and approve corrective/preventive actions
  • Establish SOPs for quality-related procedures and processes where relevant
  • Train employees within and outside of the Quality Assurance Department
  • Handle and answer internal and external (authority) audits and regulatory affairs inquiries
  • Support local, external and supplier audits
  • Support for internal/external audit finding

 

Other individual assignments 其他工作任务:

  • 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

 

Education Background: 教育背景

  • Bachelor degree or above in microbiology, biology, pharmacy or similar majors.

 

Professional Experience专业经验:

  • Minimum 5 years working experience, including at least 2 years pharmaceutical industry experience and at least 3 years quality assurance experience.
  • Good knowledge on regulatory requirements and expectations from NMPA and EU authority.
  • Ability to worked effectively in cross- organizational networks
  • Ability to influence department/process performance
  • Knowledge and experience in aseptic processing, Environment Monitoring is preferred.
  • Fluent in spoken & written English

 

 

 

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.