New Jersey GMP Auditor

Job Summary

A company is looking for a GMP (PMDA expertise) Auditor for a 3-day audit in New Jersey.

Key Responsibilities

• Conduct an internal PMDA Inspection Readiness Gap Assessment for a New Jersey facility
• Deliver an assessment report detailing gaps and remediation suggestions for compliance with Japanese GMP requirements
• Provide a web-based training presentation on Japan Health Authority Inspection Expectations and Cultural Awareness

Required Qualifications, Training, and Education

• Expertise in Japanese GMP regulations and compliance
• Experience in conducting gap assessments and audits in a pharmaceutical or biotech setting
• Ability to create detailed reports and executive summaries
• Experience in delivering training or presentations to diverse audiences
• Relevant educational background in life sciences or a related field