• Liaising with Department of Health on all regulatory issue e.g. Wholesale Licensing (western and TCM, food and nutrition), Secondary Repackaging Licensing (pharmaceutical product), import and export (pharmaceutical and food and nutrition)• Driving for changes internally in response to regulatory change in pharmaceutical field• Acting as one of the Quality in charge overseeing quality department performance and maintaining of Quality system fully compliant to Good Storage and Distribution Practice, cGMP CFR Part 210/211, Good Clinical Practice on storage and distribution of clinical trial materials, Good Distribution Practice on Medical Device and Diagnostics and ISO 9001:2008• Tackling all qualification and regular surveillance audit from various multinational pharmaceutical companies, clinical research organizations and accreditation bodies, specializing on warehousing, pharmaceutical repackaging and clinical trial quality aspects.• Partnering with Quality Assurance Manager to lead and coordinate yearly internal audit and corrective and preventive action implementation • Initiating Corrective and Preventive Action request to managers/process owners to investigate root causes of quality related issues and plan & implement corrective and preventive actions• Establishing and maintaining systematic training program for internal staff• Performing external audits to service providers and Macau distributors• Leading business development of new & special logistic service e.g. clinical trial management logistic in terms of marketing, quality standard setup & implementation and project operational setup• Supervising and leading a clinical trial team to provide logistics service to Sponsor/CRO etc. • Acting the sole pharmacist in charge on all Dangerous Drugs control in the company

• Ensuring regulatory compliance of GMP facilities• Conducting internal audit regularly on all key departments i.e. Production, Quality Assurance, Quality Control and warehouses• Liaising with health authority for expansion of GMP facilities and change of premises• Managing import quota of dangerous drugs with health authority to ensure supply chain and production continuity• Manage quality management system including establish and maintain SOP system, equipment, facility validation etc.• Handling product technical complaint, adverse event and medical affairs• Handling of product recall• Establishing and organizing a GMP Training system to various departments (e.g. QA, QC, Research and Development, warehouse, shipping and purchasing etc.)• Reforming product registration system and workflow on product registration• Managing all new product registration, change of particulars and product renewal for company