QA Engineer IV

Category:  Quality
Location: 

Tianjin, Tianjin, CN

   

Purpose of the Job

The QA engineer is responsible for all quality assurance related matters in NN Site Tianjin, ensuring high compliance with GMP requirements. Assist manager to make right decision from quality point of view.

Main Job Tasks:

  • Provide quality and compliance related input and make decisions on quality and compliance related issues.
  • Perform QA presence for responsible area and handling relevant issues.
  • Establish SOPs for quality related processes and procedures where relevant.
  • Provide training to employees within and outside of the quality assurance department.
  • Handle and answer internal and external (authority) audits and regulatory affair inquiries.
  • QA batch release as authorized qualification person by Qualified Person when need.
  • Manage supplier of local purchased material by conduct business review, evaluation and audit.
  • Review and approve operational documents requiring QA approval, including but not limited to:
  1. Standard operating procedure (SOP)
  2. Batch production record (BPR)
  3. Non-conformities(NC)
  4. Customer complain and internal complain(CC and IC)
  5. Change requests (CR)
  6. Quality activity plans(QAP)
  7. Preventative maintenance plans(PMP)
  8. Calibration specification sheets
  9. Alarm follow-up form
  10. Annual product review (APR)
  11. logbook

Other individual assignments :

  • Incorporate Novo Nordisk Way (NNW) into daily way of working.
  • Other work assigned by line manager.
  • Keep line manager accurately informed of work status as well as any problems.

Professional Experience:

  • Minimum 5 years of experience in Pharmaceutical industry including production and/or quality assurance experience.       
  • 1~3 years knowledge and experience in aseptic processing or QA assurance related area are preferred.
  • Good knowledge on regulatory requirements and expectations from NMPA and EU.                     
  • Ability to worked effectively in cross- organizational networks.                                                
  • Ability to influence department/process performance. 

Education Background:

  • 4-yr (BS) Degree or above in Pharmaceuticals, microbiology, biology related field.
  • Fluent in written and spoken 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.