QA & RA Officer

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