Wei Qi Lee

Participated in setup and accreditation of GMP laboratory, ensuring compliance with regulatory standards.

• Contributed to ensuring facility and production activities adhered to PIC/s GMP guidelines and NPRA requirements.
• Assisted in establishing new product line, supporting development and implementation of processes.
• Involved in manufacturing of cell therapy products, from isolation of Umbilical Cord-Mesenchymal Stem Cells to final product.
• Communicated with suppliers and vendors to procure new equipment, materials, and consumables efficiently.
• Streamlined inventory management processes, reducing waste and ensuring optimal stock levels were maintained.
• Effectively managed multiple competing priorities while maintaining focus on delivering exceptional results for clients and the organization.

• Prepared and cultivated cell products (MSC & NKC) in cleanroom environment, adhering to established Quality Systems and cGMP guidelines.
• Maintained accurate and complete records in compliance with cGMP requirements.
• Developed Standard Operating Procedures (SOPs) based on PIC/s GMP guidelines, ensuring alignment with ISO 9001:2005 and MS 1900:2014 standards.
• Monitored inventory levels to ensure adequate stock of materials for uninterrupted production operations.
• Performed validation studies on new methodologies before implementation into routine use, ensuring accurate test performance under various conditions.
• Trained junior staff members in proper laboratory procedures, promoting safety and compliance with regulatory standards.
• Organized repair and routine maintenance of production equipment.
• Maintained integrity of laboratory through weekly lab cleaning and maintenance procedures.
• Coordinated with the procurement department to facilitate the purchase of necessary materials.
• Supported sales team by providing accurate lead times and product availability information for customer orders.

• Conducted standardized qualitative and quantitative laboratory analyses to evaluate physical or chemical substances in samples.
• Primarily responsible for performing environmental tests, including Phenol, Ammoniacal Nitrogen, and Free Chlorine tests.
• Assisted colleagues with analysis during peak periods to ensure timely completion of customer reports.
• Collaborated with sales team to manage incoming samples and outgoing reports, ensuring effective communication with customers.
• Maintained cleanliness of work area and managed inventory of chemical reagents and apparatus alongside supervisor.