Sirui Sun

Background

About Sirui Sun

I am a senior technical services associate with a proven track record in the pharmaceutical, medical device, cosmetics, and food industries. Over the years, I have honed my skills in managing comprehensive quality assurance activities, ensuring regulatory compliance, and leading cross-functional teams. My expertise includes managing raw material and finished product specifications, deviations, Corrective and Preventive Actions (CAPA), and root cause analyses, as well as developing and implementing change control and risk assessment processes. I have successfully established and updated Good Manufacturing Practice (GMP) agreements with local and overseas suppliers, conducting thorough onsite audits to ensure compliance. In the realm of R&D and formulation optimization, I have conducted detailed assessments of New Product Development (NPD) concepts, considering quality, shelf-life, stability, and testing requirements, and have optimized formulations for commercial production readiness. I have managed diverse product categories, including food, cosmetics, listed and registered medicines, and medical devices, demonstrating expertise in various dosage forms such as tablets, capsules, liquids, gummies, bars, and beverages. Ensuring compliance with regulatory guidelines from TGA and FSANZ has been a key focus of my work. My experience extends to initiating and managing stability protocols and ongoing stability testing tailored to specific market needs, as well as coordinating analytical method transfer and validation for standardized herbals and complex dosage forms. I have directed and coordinated projects such as gummy efficacy demonstrations, regulatory submissions, and technology transfers, while efficiently managing dossier documents in Veeva System, maintaining comprehensive and accurate records of specifications, Certificates of Analysis (CoA), test reports, Standard Operating Procedures (SOPs), and internal justifications. Passionate about quality assurance and dedicated to continuous improvement, I strive to ensure the highest levels of product quality and regulatory compliance, leveraging my diverse experience and expertise to deliver exceptional results.