I’m a quality assurance professional in life science area with extensive QA/QC skills and experience in biopharmaceutical industry. I designed, implemented and executed pre-clinical and clinical studies for the development of topical anti-infectives, and intranasal and mucosal vaccines. My quality assurance responsibilities include overseeing the development and implementation of QMS for GMP manufacturing, QC testing, and clinical studies following GCP, ICH, FDA and EU guidelines.
My work at a CDMO involves a close partnership with customers to transform their concept to a quality drug, first in human study and then to market. It’s truly a rewarding experience to see scientific inventions progress forward to help patients suffering from various conditions including cancer, autoimmune disorders, neurodegenerative and rare diseases. Paying close attention to quality by design principle definitely accelerates the movement of a molecule from lab to clinic.
In simple terms, I help create miracles grounded in Science and Quality to solve health problems. It’s all about creating medicines containing superior safety, purity, potency and quality to detect, prevent or treat ailments.
I feel proud that my work contributed significantly to pull the world out of COVID pandemic, and is setting the foundation to prevent future ones.