GCP Auditor (FullTime)

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Assist with auditing activities necessary to ensure an accurate and complete submission of Eyetech sponsored projects to regulatory authorities. Assist with auditing activities throughout the development cycle of Eyetech compounds and products.

Summary

• Prepare and conduct external audit activities
• Prepare and conduct internal system audits
• Provide GCP/GLP compliance training
• Develop and review departmental SOPs
• Prepare and maintain departmental audit plans and reports for senior management

Qualifications

• BS/BA in scientific or quality-related field.
• Minimum 2 years experience in the pharmaceutical industry, preferably in Quality Assurance or Clinical Research.
• Good knowledge of FDA, GCP, GLP and ICH guidelines and regulations.
• Good medical/ scientific written and verbal communication skills.
• Ability to travel up to 25%