Adilfa Garcia

WORK HISTORY

EDUCATION

ABOUT ADILFA GARCIA

I am a highly accomplished and motivated professional with over a decade of exceptional leadership experience as a Quality Manager in the Pharmaceutical Industry. Throughout my career, I have successfully led several functional teams to drive consistency and enhancements across QA/QC, ensuring projects were completed accurately and on time in accordance with GMP and GLP requirements. I possess a comprehensive understanding of Global Regulatory Affairs and a deep knowledge of Canadian Food, Natural Products, and Drugs Regulations. My scientific research background has been a valuable asset in my work in Regulatory Affairs within the industry. I have authored comprehensive product safety and efficacy reports, meticulously collecting evidence from multiple sources, including data derived from human, animal, and in vitro experiments. These reports have been instrumental in supporting the safety and efficacy of drugs and natural products under recommended conditions of use. I have extensive experience in managing quality documents and implementing a robust end-to-end quality management system; Standard Operating Procedures (SOPs), Out of Specification (OOS), Out of Trend (OOT), Change Control, Risk Assessments, GAP analysis, Root Causes, and Corrective and Preventive Actions (CAPA). Furthermore, I have successfully led projects for the validation of production processes and equipment, as well as the qualification of suppliers for raw materials and services. These efforts have consistently yielded positive and consistent results. My exceptional organizational skills, problem-solving acumen, and team-oriented approach have been recognized throughout my career. I work well both independently and as part of a team, and my excellent communication skills enable me to collaborate effectively with stakeholders at all levels. I am deadline-oriented and thrive in fast-paced environments.