Associate Manager, Quality System, Qa

AstraZeneca

5+ years gmp quality system experience
2+ years focused on quality systems
Deep knowledge of china gmp and us fda regulations
The role involves leading the deployment and operational excellence of the AZ eQMS in China for various quality management processes

Job Summary

  • The role involves leading the deployment and operational excellence of the AZ eQMS in China for various quality management processes.
  • Candidates must ensure quality systems are fit-for-purpose, compliant with GMP, and ready for regulatory inspections across all product phases.
  • The position requires managing document governance and executing risk-based training programs to ensure staff compliance with GMP requirements.

Matching Summary

The role involves leading the deployment and operational excellence of the AZ eQMS in China for various quality management processes.

Skills & Requirements

Must-have

  • 5+ years GMP quality system experience
  • 2+ years focused on Quality systems
  • Deep knowledge of China GMP and US FDA regulations
  • Proficiency in Veeva Enterprises Quality System
  • Strong English communication skills

Nice-to-have

  • Experience with biologicals or MNC background
  • Advanced degree from 985/211 universities
  • Knowledge of ATMP and data integrity guidance
  • Risk-based training program development
  • Cross-functional collaboration capabilities

Key Requirements

  • Bachelor's degree in pharmacy or Life Sciences
  • 5+ years experience in robust GMP quality system
  • 2+ years focused specifically on Quality systems
  • Demonstrated QMS implementation/integration experience
  • Excellent English spoken and written proficiency

Work Rights

Not specified

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