QA Specialist

7 days ago


Tianjin, Tianjin, China Novo Nordisk AS Full time

Transform the Treatment Paradigm

As a QA Specialist for Medical Products marketed to the Chinese Market, you will play a pivotal role in ensuring the quality of our products meets the highest regulatory standards. Your expertise will drive innovation, transforming the treatment paradigm for chronic diseases relying on injection-based therapies.

The Position

  • Develop and implement quality management systems to ensure compliance with regulatory requirements, including cGMP, ISO 13485, and EU GMP Annex 16.
  • Lead audits and inspections, leveraging your extensive experience in GMP regulated pharmaceutical industry.
  • Collaborate with cross-functional teams to maintain a robust quality management system, ensuring seamless execution of production and quality processes.
  • Participate in signal processing, risk management, and CAPA/QMT handling to drive quality improvements.
  • Develop and maintain expertise in regulatory requirements, industry guidelines, and Novo Nordisk policies.
  • Contribute to the development of quality-related processes, ensuring alignment with external requirements and Novo Nordisk's interpretation.
  • Provide guidance and advice on cGMP interpretation, leveraging your expertise to support the organization.
  • Ensure compliance with marketing authorization, rules, regulations, and requirements regarding quality at site STJ.
  • Act as a key member of local audits and inspections, supporting the quality management team.

Qualifications

  • Bachelor's degree or Master's degree in Pharmacy, Biology, Chemistry, or a related field.
  • Excellent command of written and spoken English.
  • Minimum 10 years' experience from production or Quality area in GMP regulated pharmaceutical industry.
  • Full of experience in audit and inspection.
  • Deep understanding and expertise in regulatory requirements and industry guidelines for validation.
  • Broad experience with quality systems and standards applied by Novo Nordisk.
  • Living NN Way and Novo Nordisk policies.
  • LEAN mindset integrated with quality mindset.

Geographic Responsibility: The position is geographically placed in Tianjin, with QA responsibility in STJ. Interaction with health authorities from countries worldwide is expected due to the position's key role in inspections.



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