Key Roles and Responsibilities 

• Responsible for assisting the Head of Quality Assurance/Regulatory Affairs in maintaining the operation of the Regulatory Affairs and Quality Assurance Department to handle all regulatory related matters;
• Communicate with Department of Health and respond to their queries;
• Coordinate prompt registration of new pharmaceutical products in Hong Kong, application for change of particulars of products and renewal of product registration certificates;
• Maintain product registration files and monitor submission timeline; 
• Assist Q.A. Manager in developing the quality management systems and processes in line with Hong Kong GMP and PIC/S standard
• Handle routine quality management work including preparation of SOP, follow up of deviation, risk assessment and change control etc.
• Support Q.A. Manager during statutory inspection/ principal audit by facilitating the preparation for such audits
• Coordinate with other departments / sections regarding QA related tasks
• Support any other special tasks as assigned by the Head of Quality Assurance/Regulatory Affairs.

Qualifications and Experience

• Bachelor Degree or above in science related disciplines e.g. pharmaceutical science, quality management, chemistry, bio-medical science, food science and validations
• Relevant working experience in Quality Assurance / Regulatory Affairs of pharmaceutical or food industry
• Knowledge of GMP is essential, QMS and validation activities will be an advantage
• Excellent communication and interpersonal skills to work with people of different levels and cultures;
• Proficiency in both written and spoken English and Chinese
• Fresh graduates will also be considered

How to Apply

You are invited to send in your application and CV stating the position (with reference number) you are applying for together with your current and expected salary, apply via CTgoodjobs on or before 30 April 2025.

APT Pharma Limited is an Equal Opportunities Employer. Personal data provided by job applicants will be used strictly in accordance with our personal data policy and for recruitment purposes only. We aim to respond to successful applicants within 8 weeks and related information will be kept in our file for up to 12 months for other suitable vacancies in our organization and thereafter destroyed.