Toronto, Ontario, Canada
Experienced in Medical Research, Medical and Pharmaceutical R&D, Quality Management Systems, Quality Control Management, Process Management, Project Management; Operations Management.
• With 12 direct reports, manage raw materials and dissolution testing, OOS investigations and client communications.
• With 10 direct reports, managed and scheduled all QC testing (raw materials, packaging components, in-process / finished products and equipment) in accordance with regulations and internal standard operating procedures (SOPs) to meet production timelines. • Reviewed and approved QC batch records in laboratory inventory management system (LIMS). Released Raw Material and Packaging Components in JD Edwards (JDE). • Conducted out of specification (OOS) / deviation / product complaint investigations. Identified root causes and implemented solutions to prevent future recurrences through CAPA / change control systems. • Managed many projects, including identification scan of raw materials by Raman spectroscopy to save sampling and testing time; implemented residual solvents testing procedure to meet United States Pharmacopeia (USP) compliance. • Managed product transfer, including relevant communications with other departments and external parties. • Issued and updated QC specifications according to USP requirements. • Trained and supervised staff to ensure full understanding and adherence to requirements. • Chaired QC meetings to discuss issues of importance and identified opportunities for improvement. • Enhanced the cross-functional abilities of QC Analysts through effective training. • Conducted performance evaluations with analysts, and provided guidance for their development. • Communicated and interacted with suppliers to achieve savings and efficiencies. • Certified AQPIC (A Qualified Person in Charge) with authority to access narcotic products.
• Oversaw product transfer, antigens / antibodies purification and cell culture lab, with 5 direct reports. • Scheduled antigens / antibodies production and testing to meet manufacturing schedules. • Developed manufacturing processes compliant with GMP, ISO 13485 and Health Canada regulations. • Continuously improved processes and procedures, resulting in higher levels of quality and productivity. • Prepared stability protocols and summarized results, ensuring products met stability specifications.
• Established standard templates and protocols for transfer reports, device master records, technical files & design history files in accordance with ISO 9001, ISO 13485, and GMP requirements. • Developed / improved SOPs for processes and equipment. • Scaled-up antigens / antibodies purification processes, meeting tight manufacturing deadlines. • Conducted pilot production runs, determining appropriate manufacturing capabilities. • Managed product transfers from R&D to manufacturing. • Conducted ongoing stability studies.
Conducted primary biotech research, including improved protein purification procedures and sensitivity of immunoassay on lateral-flow devices by ELISA.
Assisted their senior consultant with ISO 9001 management system implementation at two joint-venture manufacturing plants in China.