Key skills
CommunicationRemote Work
About this role
Role Overview
- Conduct Good Manufacturing Practice (GMP) audits (planning, agenda, physical or remote audit, and report writing)
- Evaluate investigator sites, CROs, and vendor compliance or qualification.
- Prepare comprehensive audit reports detailing findings and root-causes.
- Work collaboratively with clients to ensure quality standards.
Requirements
- Minimum 10+ years of Clinical Quality Assurance and/or Good Manufacturing Practice (GMP) experience.
- Minimum 5+ years of Good Manufacturing Practice (GMP) auditing experience.
- B2 level in English communication, verbal and written
- B2 level in Japanese communication, verbal and written
- Bachelor's degree
Benefits
- Remote work options
- Comprehensive audit reports detailing findings