Sr Associate Qa

Amgen

China
Fully remote
Gdp/gsp compliance knowledge
Cgmp regulatory requirements
Quality management system execution
Amgen is seeking a Senior Quality Associate for its International & Distribution Quality team in China. This fully remote role requires oversight of drug product distribution, compliance with quality management systems, and collaboration with various stakeholders to ensure product safety and effectiveness

Job Summary

  • The role supports the International & Distribution Quality team in overseeing finished drug product distribution in China to ensure patient safety.
  • Responsibilities include conducting GSP remote and on-site due diligence visits, managing product complaints, and ensuring compliance with local regulations.
  • The position requires maintaining quality systems, supporting supplier onboarding, and collaborating with cross-functional teams to optimize communication.

Matching Summary

Match Score: 85

Amgen is seeking a Senior Quality Associate for its International & Distribution Quality team in China. This fully remote role requires oversight of drug product distribution, compliance with quality management systems, and collaboration with various stakeholders to ensure product safety and effectiveness.

Skills & Requirements

Must-have

  • GDP/GSP compliance knowledge
  • cGMP regulatory requirements
  • Quality Management System execution
  • Supplier due diligence visits
  • Product complaint handling

Nice-to-have

  • Overseas education background
  • Distribution company experience
  • Cross-functional collaboration skills
  • Independent problem-solving ability
  • Strong project management skills

Key Requirements

  • Bachelor's degree in pharmacy or related major
  • 3-5 years pharmaceutical industry experience
  • Knowledge of GDP/GSP and GMP regulations
  • Fluency in English and Mandarin

Work Rights

Not specified

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