Associate Director Quality Assurance

AstraZeneca

Qingdao, China
Gmp compliance
Validation program
Quality systems
Provide Quality support to achieve the pMDI project milestones and ensure compliance with GMP requirements during the entire life-cycle of the Qingdao capital project initiative

Job Summary

  • Provide Quality support to achieve the pMDI project milestones and ensure compliance with GMP requirements during the entire life-cycle of the Qingdao capital project initiative.
  • Responsible for ensuring GMP compliance and operational effectiveness of the validation program, including facility, equipment, utility qualifications, and computer system validation.
  • Mentor, train, and develop QA and other staff, and is a key contributor to GMP training activities, while supervising contractor and intern activities.

Matching Summary

Provide Quality support to achieve the pMDI project milestones and ensure compliance with GMP requirements during the entire life-cycle of the Qingdao capital project initiative.

Skills & Requirements

Must-have

  • GMP compliance
  • validation program
  • Quality Systems
  • change controls
  • deviations
  • AZ standards

Nice-to-have

  • automation digital processes
  • regulatory and industry trends
  • influencing stakeholders
  • fostering a culture of openness

Key Requirements

  • Expert level understanding of China legislation
  • Expert level understanding of cGMPs
  • Expert level understanding of Validation
  • Expert level understanding of Quality Systems

Work Rights

Not specified

Tailored Resume

Cover Letter