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Lexington-Fayette
Edward James

Edward James

Quality Expert for the Pharmaceutical Industry

Healthcare

Lexington-Fayette, Fayette

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About Edward James:

An expert in Quality Assurance for the Pharmaceutical Industry with 25+ years of engineering, mechanical, and laboratory background, specializing in Code of Federal Regulations (21CFR), Compendial USP Chapters, and ISO 9001 compliance.

Experience

I have extensive experience with regulatory compliance for the pharmaceutical industry. Specific skills include relevant sections of 21CFR for current Good Manufacturing Practices, Quality System Regulation, and Electronic Records and Electronic Signatures. Additional skills include compliance to European Union EudraLex Volumes related to medicinal products for human use. Hosting of audits for compliance to FDA, DEA, MHRA, Third-Party Organizations, Suppliers and Vendors.

Education

I earned a Bachelor of Science degree in both Chemistry and Physics, including Post-Graduate Studies in Particle Physics as a hobby.

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