Job Description & How to Apply Below
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
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