Xin Yee Leong Email & Phone Number

Detail-oriented Quality Assurance Specialist with a Master’s Degree in Process Validation and Regulatory Affairs (Pharmaceutical). Experienced in leading internal and supplier audits, managing quality systems like GMP, ISO9001, and ISO22000, and driving continuous improvement initiatives. With an extensive background in the food industry and academic expertise in the pharmaceutical and medical device sectors (including process validation, ISO 13485, ICH Guidelines, FDA & EMA regulations, risk assessment, and process engineering), I excel in product quality management, audit management, document compliance & control, and leading quality troubleshooting (CAPA management). Proven track record of enhancing operational efficiency, reducing costs, and ensuring compliance with stringent quality standards. Fluent in English, Mandarin, and Malay. Passionate about quality management and dedicated to achieving excellence in pharmaceutical, medical device, and food & beverage industries.