R&d Clinical Quality Assurance Senior Specialist

Merck Sharp & Dohme Corp

Hybrid
Gcp auditing experience
Knowledge of ich-gcp regulations
Fluent in japanese and english
The QA team focuses on ensuring high-quality, safe, and effective products throughout the product development lifecycle

Job Summary

  • The QA team focuses on ensuring high-quality, safe, and effective products throughout the product development lifecycle.
  • The role involves conducting GCP audits and ensuring compliance with global regulatory requirements.
  • Candidates will contribute to team goals while enhancing their personal skills and leading specific tasks.

Matching Summary

The QA team focuses on ensuring high-quality, safe, and effective products throughout the product development lifecycle.

Skills & Requirements

Must-have

  • GCP auditing experience
  • Knowledge of ICH-GCP regulations
  • Fluent in Japanese and English

Nice-to-have

  • Ability to collaborate with global teams
  • Strong analytical skills
  • Experience with Veeva Vault QMS

Key Requirements

  • BS/BA degree or equivalent
  • 5+ years of GCP auditing experience
  • Experience with clinical trial processes

Work Rights

Not specified

Tailored Resume

Cover Letter