Quality Advisor/Senior Consultant
Yvette Gonzalez Cuascut obtained her Bachelors Degree in Chemistry from Pontificia Universidad Catolica de Puerto Rico. She has over 20 years of experience in industries such as Johnson and Johnson, Roche Diagnostics, Amgen Biotech, Wyeth Pharmaceuticals, Ben Venue Labs and Abbott Nutrition among others. Her work experience includes Laboratory Analyses, Production Planning, Quality, Compliance, and other systems for processes like Regulated Environments, Nutrition and Consumer Health Products.
Mrs. Gonzalez has vast expertise as Chemist, Lead Auditor, Supplier Management and Training. More recently, as a Consultant, she has helped these companies to achieve success in areas like FDA Audits, ISO Audits, Effective Product Transfers, System Validations, develop Training Programs and design Trainings.
Yvette has vast hands on experience on the fields of System Audits, Train the Trainer,
Problem Solving Techniques for CAPA, Non Conformances and more recently for Investigations Handling with emphasis on Human Error Reduction and also on Human Error Prediction. She has completed her studies and applied her knowledge on companies in Puerto Rico, USA and Dominican Republic.
Technical Advisor/ Business Executive Officer
Andres Velázquez, has more than 15 years combined worth of experience in the biotechnology, medical device industries, OTC, pharmaceutical industries, validation, compliance, quality contractor/consulting industries. Experience in such industries includes USA, PR, Dominican Republic and UK.
Velázquez has a MS from Polytechnic University of PR and BS degree from University of PR. Has worked for important pharmaceuticals, such as Elli Lilly, Amgen, Abbott, Merck, Cardinal Health, J&J, Schering-Plough (now Merck), Wyeth, Pfizer, Ben Venue Labs, Perrigo, Bristol Myers Squib, Warner-Chilcott, Glaxo Smithkline, among others.
Other areas of expertise are Validation Consultant in Solid Dosages Product Transfer areas with major pharmaceutical manufacturing industries, (solid dosage, critical utilities, suspensions, aqueous solutions, control systems, aseptic processing, medical devices) and Biotechnology Companies, including 21 CFR Part 11 components of Emerson DeltaV DCS process control systems, including Regulatory Control, Operator Interface and Batch Management in Purification and Fermentation equipments.
Experience also includes design and development of project plans, scope of work, cost estimates, schedules, validation protocols, QA audits and reviews, performing of GAP analysis. Also, with validation, qualification, and commissioning, Human error reduction programs, Human error prediction, cognitive load assessments, human reliability, Root Cause Analysis and QA Audits.
Velazquez has managed effectively site safety and regulatory inspections to comply with ISO, FDA.
CARMEN AMENGUAL, M. S.
Training and Development Advisor
Carmen Amengual has over 30 years experience in the Pharmaceutical industry in the areas of Supply Chain, Packaging, Quality and Human Resources.
Amengual training expertise is in the design, development, delivery and implementation of training systems, plans and operational structure in the following environments: tablets, capsules, injectables, liquids and nasal sprays filling manufacturing and packaging.
Amengual has provided consulting services to a Medical Device client maker of intraocular lenses, focusing in the area of On the Job Training for manufacturing operators and designing training materials. She has also designed the measurement and evaluation methods to evaluate training effectiveness. In addition, she has developed technical training, cGMP modules, process flowcharting, skill qualification and Emotional Intelligence
for Supervisors and Managers.
Prior to joining GCI Human Reliability Consulting, Ms. Amengual worked as Site Technical Training and Qualification Supervisor for Schering Plough which at the time was under a Consent Decree. She also worked for Smithkline Beecham, Roche Products and Searle & Co. Ms. Amengual is a Certified Train the Trainer, Instructional Design Trainer and Quality Trainer.
Amengual has a BA degree from University of Puerto Rico and a post graduate degree, M.S Industrial/Organizational Psychology from Carlos Albizu University.
Process Advisor / Business Development Manager
Orlando Perez-Osorio obtained his Bachelors Degree in Industrial Engineering from Universidad Politécnica de Puerto Rico. He has over 25 years of experience in industries such as Ben Venues Laboratories, GMC Inc., McNeil, Novartis, Johnson and Johnson, Pall Life Sciences, Corning Cable Systems and Panasonic, Ltd. His work experience includes designing, establishing and managing Quality, Compliance, Training and other systems for processes like Regulated Environments, Medical Devices, Consumer Health Products,
Communications and Electronics.
All of the projects that Mr. Perez have completed using his expertise as Engineer, Lead Auditor, Manager and lately as a Consultant on Training and Quality Systems have helped these companies to achieve success in areas like FDA Audits, ISO Audits, CEE Audits, UL Qualifications, New Products and Processes Development, Design and Improvement. He has also used his quality systems knowledge to establish small hand made products companies.
Orlando have studies and hands on experience on the fields of Project Management, System Audits, Effective Supervising, Train the Trainer, Six Sigma, Problem Solving Techniques for CAPA, Non Conformances, Computerized Tools Design and more recently on Investigations Handling with emphasis on Human Error Reduction. He has applied his knowledge on companies in Puerto Rico, USA, United Kingdom and Dominican Republic.