Associate Manager, Quality System, Qa

AstraZeneca

Suzhou, China
Eqms implementation
Document control
Change control
Lead the local implementation and operational excellence of AstraZeneca's eQMS in China, covering document control, training, change control, deviations, and CAPA

Job Summary

  • Lead the local implementation and operational excellence of AstraZeneca's eQMS in China, covering document control, training, change control, deviations, and CAPA.
  • Partner with global teams and local champions to ensure consistent system setup, process adherence, and issue resolution for eQMS implementation and cell therapy quality management.
  • Develop and execute risk-based training programs to ensure personnel understand and comply with GMP requirements, internal standards, and quality management system processes.

Matching Summary

Lead the local implementation and operational excellence of AstraZeneca's eQMS in China, covering document control, training, change control, deviations, and CAPA.

Skills & Requirements

Must-have

  • eQMS implementation
  • document control
  • change control
  • deviation management
  • CAPA management
  • GMP compliance

Nice-to-have

  • cross-functional collaboration
  • continuous improvement
  • risk-based training
  • regulatory inspection readiness

Key Requirements

  • Bachelor’s degree in pharmacy, Life Sciences, Biotechnology or related field
  • 5+ years of experience in a robust GMP quality system
  • 2+ years focused on Quality system
  • Demonstrated QMS implementation/integration experience
  • Proficiency in quality risk management
  • Deep knowledge for China GMP, US FDA 21 CFR, EU GMP, PIC/S, ICH Q9/Q10, ATMP and data integrity

Work Rights

Not specified

Tailored Resume

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