Manuel Estrello

I am an analytical chemist with extensive experience in method development, method validation, and stability testing within GMP/GLP/ICH environments, supporting regulatory compliance for FDA, EMA, and COFEPRIS. I specialize in HPLC, GC, dissolution, IR, and AA and apply ALCOA+ principles across laboratory documentation and testing.

Throughout my career I have led OOS/OOT investigations, authored CAPA and MOC documentation, and supported audit and inspection readiness. I bring process-improvement expertise using statistical tools and Lean Six Sigma methods to optimize analytical workflows and ensure data integrity.

I am a bilingual communicator who has trained and supervised laboratory teams, developed technical and academic content, and maintained strict adherence to controlled documentation and regulatory requirements—delivering reliable results in fast-paced, highly regulated environments.