Define and plan validation activities to meet the cGMP requirements, coordinate with end users and process owners to develop and execute validation protocols for manufacturing facilities, systems, process and/or software; analyze validation related issues, implement validation related event, Change Control and CAPA.
Support timely compilation and submission of dossiers for approval of product registration, change of particulars and renewal, communicate with Department of Health and respond to their queries, provide regulatory support to internal departments.
Sampling and testing of raw materials, packaging materials, purified water, in-process samples, finished products and stability studies samples, operation of laboratory equipment, assisting in laboratory equipment calibration, qualification and maintenance.
Prepare and revise QC SOP and GMP documents, assist in implementing and maintaining the documentation system, prepare validation and qualification documents, conduct product quality review, develop QC training program.
Perform clerical duties and provide general administrative support, prepare purchase order and inventory control record.
Operate all quality related activities in Good Manufacturing Practice ensuring safety and quality of drug manufactured, review process control plan, track drug quality performance, assist drug regulatory registration in Hong Kong and overseas.
Supervise day-to-day running of QC laboratory, including daily testing, monitoring laboratory operations and test turnaround time, performing test methods development and validation.
Perform sampling of purified water and finished products, assist in the microbiology laboratory operation, prepare test report and assist in quality control operations.
