Senior Specialist, Quality System, Qa

AstraZeneca

5+ years gmp quality system experience
Change control process champion expertise
Deep knowledge of china us eu gmp regulations
The role serves as the primary champion for site change management processes ensuring compliance with current GMP requirements

Job Summary

  • The role serves as the primary champion for site change management processes ensuring compliance with current GMP requirements.
  • Candidates must review site-initiated change controls to confirm risks are thoroughly assessed and mitigation plans are properly defined.
  • The position requires leading cross-functional teams to ensure consistent application of key quality systems across the organization.

Matching Summary

The role serves as the primary champion for site change management processes ensuring compliance with current GMP requirements.

Skills & Requirements

Must-have

  • 5+ years GMP quality system experience
  • Change control process champion expertise
  • Deep knowledge of China US EU GMP regulations
  • Strong risk management and data integrity skills
  • Experience with biologicals or Cell Therapy ATMP

Nice-to-have

  • MNC background preferred
  • Veeva QMS systems experience
  • ASQ quality certifications
  • 985/211 university graduate
  • Proactive continuous improvement mindset

Key Requirements

  • Bachelor's degree in pharmacy or Life Sciences
  • Minimum 5 years pharmaceutical GMP experience
  • At least 2 years focused on Quality systems
  • Proficiency in English documentation and communication
  • Knowledge of ICH Q9/Q10 guidelines

Work Rights

Not specified

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