Daisy Chew

Consultant @CAI

Serving pharma and biotech industry in a variety of consulting capacities: program and project management, scheduling, technical writing, quality and compliance, deviation investigations, robotics, FAT, C&Q, supply chain, aseptic processing, clean rooms KEY PROJECTS THROUGH CAI: Robotics Program Manager • Oversaw program portfolio for robotic system deployment across global sites from requirements/design phase to FAT, install, SAT, system handover Project Scheduler • Created and managed project schedules in Primavera P6 and MS Project Parts Planner • Coordinated parts delivery for medical device assembly lines across multiple sites Deviations Investigator • Investigated deviations in warehouse/supply chain, packaging, and visual inspection areas C&Q Engineer • Authored and executed commissioning, qualification, and validation documentation on a variety of systems in pharmaceutical manufacturing plant Director of Operations • Oversaw operations during build phase of small pharmaceutical company Human Performance Consultant • Analyzed human performance influencers for deviation management, developed interventions, implemented programs in contract biotech manufacturing facility Technical Writer • Authored quality plans, maintenance plans, investigation and audit responses, SOPs, training materials, and reports Facility Start Up Consultant • Developed expedited onboarding and training strategy for operators in a cell culture and scale up facility using roller bottle technology • Managed MSAs and selection of staff from several subcontractor partners Quality Systems Consultant • Prepared FDA inspection readiness documentation • Oversaw change plan for LMS implementation Instructional Designer • Designed synchronous, asynchronous, in-person, and eLearning training modules on GMP and non-GMP topics