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Senior Specialist, Quality System, QA

📍 AstraZeneca • Su Zhou Shi, Jiang Su Sheng, China • Posted June 07, 2026

Full-time Posted June 07, 2026
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Job Description

Major responsibilities

  • Global Alignment & Harmonization: Map site procedures to corporate/global SOPs, harmonize terminology and process flows, and drive adoption of global standards, templates, and metrics. Lead gap assessments and remediation to ensure full integration and consistency.
  • Implement ECMS at Suzhou site: Work with global project team to promptly execute global ECMS implementation and project timeline at Suzhou site as local representative.
  • Clinical Lifecycle Readiness: Ensure controls support tech transfer from development to GMP clinical supply, scale‑out/scale‑up, protocol amendments, and eventual commercial transition.
  • Document Control: Establish controlled lifecycle management for SOPs, policies, work instructions, forms, and templates; ensure controlled issuance, versioning, approval, periodic review, and archival in the electronic system.
  • Data Integrity: Implement ALCOA/ALCOA+ principles for paper and electronic procedures ...

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