Hanifah Adewumi
Stability Quality Assurance Manager @AstraZeneca
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WORK HISTORY
Stability Quality Assurance Manager @AstraZeneca
CMC Consultant: Thorough understanding of pharmaceutical stability testing and a full overview of operations activities and how this contributes to achieving the objectives of the business • Plans, designs, and executes multiple simultaneous projects with internal and external cross functional stakeholders • Attend CMO calls and provide specific information to the POC • Technical support related to Stability (Product Complaint, Deviations, Change Controls). • Investigate Out of Trend or Out of Specifications stability results, aid in Corrective and Preventative Actions (CAPAs) • Acts as a SME (Subject Matter Expert) for drug substance and drug product batches that are monitored; Provide formal responses to all contractors • Review interim reports for multiple batches • Assist with the generation and maintenance of the Stability Program for assigned products (such as protocols) • Building Stability Modules in GQCLIMS Labware 6; Utilize GQCLIMS to monitor and maintain stability testing including Stability Static Data-load • Create product specs, testing and calculations in GQCLIMS • Responsible for providing support coordination and preparation of stability sections for regulatory submissions; Develop report and other deliverables for the bi-weekly submission to various stakeholders (author/co-author relevant regulatory filing sections) • Identification of any quality issues that may result in stability related,non-compliance with GMP, regulatory requirements • Proficient in Trackwise and Veeva Vault
EDUCATION
University of Maryland Eastern Shore
Bachelor's degree, Biology, General
Walden University
Master of Healthcare Administration
ABOUT HANIFAH ADEWUMI
Working in quality assurance, I leverage my 6.5+ years of experience in analytical…
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