Verified recordBiotechnology Research

Lucy Mwakisachi

Qa Document Control Specialist at Kite Pharma

Based in Frederick, United States

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Seniority

Staff

Department

Information Technology

Location

Frederick

Industry

Biotechnology Research

Company size

4K

Contact information

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Email

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l•••••••@kitepharma.com

Phone

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Background

About Lucy Mwakisachi

Results-oriented Quality Assurance and Health Management professional with 10+ years of experience in Good Clinical Practice (GCP) and 5+ years in Good Manufacturing Practice (cGMP) quality systems. A proven ability to establish and manage robust quality management systems, including stringent document and change control procedures and CAPA activities. Expert in navigating complex regulatory landscapes (ICH, FDA), leading global clinical studies, and ensuring product quality and regulatory compliance. Particularly successful in resource-constrained environments focused on infectious diseases in Sub-Saharan Africa. Seeking a challenging role to leverage expertise in delivering high-quality products, improving process efficiency, and contributing to continuous improvement initiatives.

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