Pure Source
Director of Quality
Pl Developments Apr 2010 - Mar 2019
Senior Director of Corporate Quality
Azopharma Contract Pharmaceutical Services Oct 2004 - Apr 2010
Senior Director, Quality Assurance
Education:
Pontificia Universidad Católica De Puerto Rico - Recinto Arecibo 1975 - 1979
Bachelors, Bachelor of Science
Skills:
Gmp Quality Assurance Validation Change Control Pharmaceutical Industry Gxp Fda Capa 21 Cfr Part 11 Quality System Sop Glp Quality Control Quality Auditing Quality Management V&V Regulatory Affairs Analytical Chemistry Cleaning Validation Technology Transfer Pharmaceutics Lims Drug Development Fda Gmp Regulatory Requirements Protocol Formulation Chromatography Aseptic Processing Biopharmaceuticals Regulatory Submissions Computer System Validation Hplc Dissolution Anda Iso 13485 Ich Guidelines 21 Cfr Gas Chromatography Analytical Method Validation Trackwise Quality By Design Gamp Deviation Management Usp Ind Quality Systems Equipment Qualification Uv