A consultant, project manager, and engineer with years of experience in the FDA regulated work environment. Provide service of
1) quality system (supplier audit, CAPA, document control, validation, ... )
2) continuous improvement (Lean, Six Sigma, Kaizen)
3) outsourcing (assessment, audit, validation, documentation, and training)
4) project management (planning, implementation, change management)
5) training (cGMP, documentation, validation, Lean, Six Sigma)
Specialties: Quality Management, Project Management, Outsourcing, Continuous Improvement, and Training,