Associate Manager, Quality System, Qa

AstraZeneca

China
Az eqms implementation
Gmp document control
Risk-based training programs
Lead Local Implementation of AZ eQMS for document control, training, change control, deviation, CAPA, etc. in China

Job Summary

  • Lead Local Implementation of AZ eQMS for document control, training, change control, deviation, CAPA, etc. in China.
  • Manage phase appropriate quality management system to ensure they are fit for different product phases and compliant with regulations.
  • Develop and execute risk-based training programs to ensure personnel understand and comply with applicable regulations and GMP requirements.

Matching Summary

Lead Local Implementation of AZ eQMS for document control, training, change control, deviation, CAPA, etc. in China.

Skills & Requirements

Must-have

  • AZ eQMS implementation
  • GMP document control
  • risk-based training programs
  • China GMP compliance
  • US FDA 21 CFR
  • EU GMP
  • ICH Q9/Q10

Nice-to-have

  • cross-functional collaboration
  • continuous improvement
  • strong ownership
  • self-motivation
  • rigorous logical thinking

Key Requirements

  • Bachelor’s degree in pharmacy, Life Sciences, Biotechnology
  • 5+ years of experience in robust GMP quality system
  • 2+ years focused on Quality system
  • Excellent English (spoken and written)

Work Rights

Not specified

Tailored Resume

Cover Letter