Responsibilities:

• Take the lead in implementation, establishment and development of company’s quality system and quality manual
• Manage and control GMP documentations, approve and supervise the activities of quality management system including product complaint & recall, internal & external audits, vendor management, deviation management, CAPA, change Control and quality risk management
• Responsible for compliance with technical or regulatory requirements related to the quality of finished products and the approval of the release of finished product.
• Ensure the requirements of marketing and manufacturing authorization for the product have been met.
• Monitor and control activities of dangerous drugs and substances
• Work with Sales & Marketing department and R&D department in product development, provide technical knowledge and compliance advice on product quality and safety
• Manage the work of various departments including QC, QA, production, engineering, logistics, R&D department, validation, PIC/S GMP compliance, etc.
• Delegation of functions to designated person with appropriate qualifications and experience in the change of personnel

Requirements:

• Bachelor degree or above in Pharmacy or related discipline
• Pharmacist registered with the Pharmacy & Poisons Board of Hong Kong
• On list Authorized Person of Pharmacy & Poisons Board of Hong Kong
• Relevant experience in HK pharmaceutical industry with GMP manufacturing background
• Familiar with the HK regulatory requirements of GMP and PIC/S
• Exposure in PRC pharmaceutical industry and knowledge of PRC pharmaceutical regulation is an advantage.
• Strong interpersonal and communication skills;
• Good command of both spoken and written English, Cantonese and Mandarin.