With his project management skills and ability for prioritizing, Matthew is a valuable addition to the Q&C^®/ValidaPharm^™ teams and an asset on any project. He is a quick learner who can efficiently integrate his knowledge and experience in validation and GMP environments into project activities. Bright and very capable, he works well as a team member or independently, and is able to establish and meet timelines for activities.

Validation

• Performed qualification (IQ, OQ, PQ) of product equipment and plant utilities, including reactors, dryers, HVAC systems, clean rooms, and DI water systems, for Canadian pharmaceutical manufacturer.
• Performed computer system validation on process control system.
• Updated change control documentation to reflect new equipment and modifications to qualified equipment.
• Managed qualification and validation activities, to ensure new equipment was commissioned on schedule, for large drug manufacturing company.
• Assisted with the execution of cleaning validation protocols for equipment for a large pharmaceutical company.

Quality Assurance/Quality Control

• Developed/revised SOPs and documentation for drug, natural health product, and medical device importers and distributors.
• Applied GMP knowledge to develop SOPs for a pharmaceutical packager.
• Managed environmental monitoring (EM) program for Canadian pharmaceutical manufacturer.
• Trained employees in use of equipment and clean room behaviour.
• Addressed deviations and resulting corrective actions.
• Implemented innovative data analysis procedure to determine root cause of EM program failures, resulting in a 70% decrease in excursions.

• Bachelor of Applied Science, Engineering Science: Biomedical Engineering, University of Toronto, Toronto, Ontario

• Aerial personnel lift operation
• Cleaning Validation and Critical Cleaning Processes - Institute of Validation Technology
• Computer Systems Validation
• Confined Space Entry
• Controlled Drug and Substance Handling, PSG
• Fundamentals of Regulatory Affairs, CanReg
• GAMP Good Practice Guide: Calibration Management
• GMP for Importers/Distributors, Q&C
• Good Automated Manufacturing Practices (GAMP 4)
• Good Documentation Practices
• Good Manufacturing Practices (finished products and active pharmaceutical ingredients)
• Lock-out/tag-out procedures
• SOP Writing
• Technical Writing Course, Q&C
• WHMIS certification