Javier Santiago
About Javier Santiago
Javier Santiago is a Senior QA Scientist at Bristol-Myers Squibb in Puerto Rico with extensive experience in quality assurance, validation, and laboratory operations across multiple pharmaceutical companies.
Company
Javier Santiago currently serves as a Senior QA Scientist at Bristol-Myers Squibb in Puerto Rico. His extensive experience across different companies such as Novartis, Pfizer, and Neolpharma has made him a valuable asset in the pharmaceutical industry. His role typically involves ensuring compliance with all procedures, managing audit observations, and supporting both internal and regulatory inspections.
Title
As a Senior QA Scientist, Javier Santiago supports the Quality perspective in manufacturing areas, including both Oral Solid Dosage (OSD) and Parenteral products. His responsibilities also include managing audit observations, investigations, change controls, and CAPAs records in Trackwise. Santiago also assists management during internal and regulatory inspections.
Education and Expertise
Javier Santiago earned a Bachelor Degree in Science, specializing in Chemistry, from the University of Puerto Rico. His professional expertise includes stability indicating methods, OOS, dissolution profiles, and bioequivalence/bioavailability. Santiago has implemented laboratory computer systems according to USP <1058> Analytical Instrument Qualification, and is proficient in computer system validation, risk assessment, and the maintenance phase.
Background
Javier Santiago has a robust background in Quality Assurance, Validation, and Laboratory Operations. His career began at Ortho-McNeil Pharmaceutical as a Laboratory Senior Analyst, and spans over two decades across leading pharmaceutical companies such as Pfizer, Genzyme Sanofi, and Allergan. Santiago has extensive experience in implementing remediation plans for laboratory deviation/CAPA systems, conducting audits of stability programs, and ensuring compliance with regulatory and compliance standards.
Achievements
Javier Santiago has managed audit observations, investigations, change control, and CAPAs records effectively across his career. He has reviewed and approved all process, product, and computer systems validation protocols and reports, ensuring compliance of all procedures to avoid regulatory issues. His contributions have supported internal and regulatory agency inspections, including those by the FDA, DEA, and MCA.