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Chandler Lyons
Api Manufacturing Manager (Cleaning and Process Validation) @Pfizer
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WORK HISTORY
Api Manufacturing Manager (Cleaning and Process Validation) @Pfizer
Kalamazoo, MI, US
Develop strategies and documents for cleaning and process validation of Active Pharmaceutical Ingredient (API) equipment and products in compliance with site SOPs and regulatory guidance, including process validation protocols and reports, cleaning validation protocols and reports, and cleaning records-Optimize current cleaning procedures through improved solubility based on cleaning solvents used, use of cleaning detergents such as CIP 100 and 200, recycle times, and historical trending-Determine impact of processing deviations to cleaning and process validation-Support 24/7 plant operations with timely responses to complex validation concerns or cleaning failures-Lead cleaning failure investigations (analytical and visual failures) and determine and implement Corrective Actions and Preventive Actions (CAPAs)-Defend the validation programs and strategies to internal, customer, and regulatory auditors-Author Quality Risk Management (QRMs) memos and Quality Memos to support the cleaning and process validation programs.
EDUCATION
Forest Hills Central High School
General Education, College Preparatory
Tulane University
Bachelor's Degree
SKILLS
ABOUT CHANDLER LYONS
API Manufacturing Manager at Pfizer
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