Pharmaceutical Quality GMP Auditor – Consulting

This is a fully remote position, open to applicants in Japan.

📋 Description

• Perform audits in accordance with Good Manufacturing Practice (GMP), including planning, scheduling, conducting physical or remote audits, and writing reports.

• Assess compliance or qualification of investigator sites, Contract Research Organizations (CROs), and vendors.

• Create thorough audit reports that outline findings and identify root causes.

• Collaborate effectively with clients to uphold quality standards.

⛳️ Requirements

• At least 10 years of experience in Clinical Quality Assurance and/or Good Manufacturing Practice (GMP).

• A minimum of 5 years of experience specifically in Good Manufacturing Practice (GMP) auditing.

• Proficient in English communication at a B2 level, both verbal and written.

• Proficient in Japanese communication at a B2 level, both verbal and written.

• Bachelor's degree required.

🏝️ Benefits

• Options for remote work.

• Detailed audit reports that comprehensively outline findings.