Job Responsibilities 1. File and Record Management: Assist in the drafting, review, distribution and archiving of SOPs, batch production records, etc. GMP documents, maintain various quality archives and records, and ensure their accuracy, completeness and compliance. 2. On-site Monitoring and Audit: Responsible for daily production site inspections, supervise key process parameters, cleaning operations and sanitation compliance; participate in internal and supplier audits, and assist in completing the preparation work for Hong Kong Health Authority and overseas customers. 3. Quality Event Handling: Responsible for the preliminary investigation, information collection and record report of deviations, OOS (out of specification), OOT (out of trend) and changes, and track the execution and effectiveness validation of CAPA (corrective and preventive actions). 4. Release and Traceability Support: Review raw materials and product batch production records, test reports and related documents, assist in completing the product release process, ensure that the whole process meets the quality requirements and has complete traceability.

Requirements 1. Education and experience: Bachelor's degree or above in pharmacy, pharmaceutical engineering or related fields, with at least 3 years of practical experience in quality assurance in pharmaceutical companies. 2. Professional knowledge: Familiar with the Hong Kong Traditional Chinese Medicine Ordinance and GMP regulations, understand the basic requirements of Chinese mainland pharmaceutical GSP/GMP, and grasp the handling process and principles of deviations, changes, etc. quality events. 3. Core skills: Able to independently carry out production site monitoring, GMP document review and quality event preliminary investigation; with basic document writing skills and audit preparation experience. 4. Professional ethics: Work rigorously and meticulously, with strong principles, good communication and coordination skills and team spirit, and able to meet the cross-departmental quality supervision and support work.