Over eighteen years of experience in the validation of pharmaceutical and biotechnology equipment, computerized systems, and utilities (heating, ventilation, air conditioning (HVAC), water, clean steam, compressed gases) in cGxP regulated environments for major pharmaceutical and medical device companies in Canada, USA, and Europe to establish and maintain quality and compliance with company specifications, GxP regulatory requirements, current industry standards, and best practices.
Expert in the validation of pharmaceutical water systems for USP purified water (PW) and USP water for injection (WFI), entailing specification, design, and testing of equipment and systems for water generation, storage, and delivery.
Tactical thinker, effectively managing and coordinating multiple large-scale projects simultaneously. Support planning, procurement, and completion of assigned projects. Authoring of system lifecycle documents, including validation plans, high-level classification documents, specifications (functional, user-requirement, design) functional risk assessments, commissioning and qualification protocols, final reports, traceability matrices, validation summary reports, and standard operating procedures (SOPs). Perform execution of commissioning and qualification protocols, including identification and resolution of non-conformances and deviations.
Expertise in: System Lifecycle Management / Technical Writing / Change Management / Good Manufacturing Practices (GMP) / Good Laboratory Practices (GLP) / Good Engineering Practices (GEP) / Code of Federal Regulations (CFR) Title 21 Part 11, Part 58, Part 210, & Part 211.