R&d Clinical Quality Assurance Senior Specialist

539

Tokyo, Japan
Hybrid
Gcp auditing in apac region
Prepare and conduct qa audits
Quality risk management
Our QA focuses on quality across the product development lifecycle, ensuring high-quality, safe, and effective products to improve lives and save lives globally

Job Summary

  • Our QA focuses on quality across the product development lifecycle, ensuring high-quality, safe, and effective products to improve lives and save lives globally.
  • QA Clinical Quality (CQ) provides independent assurance through robust processes and procedures to ensure participant safety, rights, and well-being, and data integrity in clinical trials while complying with global regulatory requirements.
  • This role involves leading specific tasks within the team, prioritizing time and effort towards critical deliverables, and producing high-quality work.

Matching Summary

Our QA focuses on quality across the product development lifecycle, ensuring high-quality, safe, and effective products to improve lives and save lives globally.

Skills & Requirements

Must-have

  • GCP auditing in APAC region
  • Prepare and conduct QA audits
  • Quality risk management
  • PMDA investigator interaction
  • Veeva Vault QMS system

Nice-to-have

  • Drive continuous process improvement
  • Develop new audit techniques
  • Foster positive workplace culture

Key Requirements

  • 5+ years GCP auditing experience
  • Knowledge of ICH-GCP and PMD Law
  • Experience in clinical trial processes
  • Experience with CAPA proposal and follow-up
  • Global team or multinational project experience

Work Rights

Not specified

Tailored Resume

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