Elisa Miraglia
About Elisa Miraglia
Elisa Miraglia is a Quality Assurance Specialist and Regulatory Affairs professional at Ingenus Pharmaceuticals in Lugano, Switzerland. She holds a Master's degree in Cellular and Molecular Biology and has extensive experience in managing quality compliance and regulatory processes in the pharmaceutical industry.
Work at Ingenus Pharmaceuticals
Elisa Miraglia has been employed at Ingenus Pharmaceuticals since 2018. Initially, she served as a Quality Assurance Trainee for four months before transitioning to her current role as Quality Assurance Specialist & Regulatory Affairs in 2020. In this capacity, she manages the company's training system to ensure compliance with quality regulations and drafts and revises standard operating procedures to maintain regulatory compliance. Additionally, she conducts trend analysis of key product quality parameters and prepares electronic Common Technical Documents (e-CTDs) for generic drug registration in the United States.
Education and Expertise
Elisa Miraglia holds a Bachelor's degree in Biological Sciences from the University of Catania, which she completed from 2010 to 2014. She furthered her education with a Master's degree in Cellular and Molecular Biology from the same institution, graduating in 2017. Additionally, she completed a Second Level University Master Course in Industrial Pharmaceutical Technologies at the University of Siena from 2018 to 2019. Her educational background provides her with a solid foundation in biological sciences and pharmaceutical technologies, which supports her work in quality assurance and regulatory affairs.
Background
Elisa Miraglia began her professional journey as a Trainee at Università degli Studi di Catania from 2013 to 2014. This early experience contributed to her understanding of the biological sciences field. After completing her studies, she joined Ingenus Pharmaceuticals, where she has developed her expertise in quality assurance and regulatory affairs over several years. Her work is primarily based in Lugano, Canton Ticino, Switzerland.
Achievements
In her role at Ingenus Pharmaceuticals, Elisa Miraglia has been involved in significant regulatory activities, including supporting audits by regulatory authorities such as the FDA and Swissmedic. She implements corrective actions as needed to ensure compliance with regulations. Her responsibilities also include evaluating the regulatory impact of changes on registered products, showcasing her ability to navigate complex regulatory environments effectively.