Sunil Desouza
Senior Manager, R & d Quality @AbbVie
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WORK HISTORY
Senior Manager, R & d Quality @AbbVie
Irvine, CA, US
EDUCATION
Arizona State University
M.S. Chemistry, Analytical Chemistry
St. Xavier's College
B.S., Chemistry
Rhodes Scholar-Finalist (India)
University of Oxford-UK
St. Andrew's Jr. College
HSC, Science
SKILLS
ABOUT SUNIL DESOUZA
Certified Quality Auditor (CQA)- certified by the American Society for QualityCertified Lead auditor for ISO 13485 and MDSAP - Conducted internal audits of various functional areas in the GMP manufacturing and laboratory environment. Review findings with management and discuss plan for completion of corrective and preventive (CAPA) actions and documentation in the quality management system (QMS) record. Review multi-phase validation protocols and reports, technical transfer documents, incident and deviation reports, review of methods, stability protocols, drug substance/product specification documentation and other GMP technical documents to ensure compliance with local SOP’s and US and international regulations.Monitor CRO manufacture and testing of drug substance (API) and drub product.Review deviation/out of specification incidents and review associated investigations and CAPA. Approve all associated documentation.Proficient with the use of QMS software to manage and track deviations, incidents, complaints, audits and other quality events.Evaluate temperature excursion incidents to establish clinical product integrity and complaint investigations.Rhodes Scholarship (All India Finalist) University of Oxford, England.Represented the USA Masters Men\'s field hockey team at the World Cup in Barcelona, Spain-August 2018Selected to represent the USA Masters Men\'s field hockey team at the European Championships at Krefeld, Germany - August 2019
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