Page 36 - HSEL UK Ltd Company Information 1

Our Consultants
Colin Smith - Consultant - Biography
Colin Smith has over 20 years’ experience in current Good Manufacturing Practices (GMP) industry for manufacture of medicines and clinical products.
Colin started in the industry as a warehouse stores person in a flu vaccine manufacturing business in Liverpool, culminating in his current work with numerous biotechnology companies to assist them in (primarily) startup operations.
Colin has assisted numerous pharma clients start up their businesses including:
Medimmune UK Ltd, Alvotech, MeiraGTx, Cell Medica and ADC Biotechnology.
Colin’s main skills are:
◆ A skilled classroom trainer/facilitator specialising in concept GMP compliance training, technical writing, and documenting investigations.
◆ Continuous Improvement (CI) principles and behaviour. Driven and actively involved in the introduction and implementation of a CI culture in his previous roles.
◆ Lean Six Sigma Green Belt Certified, using sigma and risk analysis tools to realise business improvements. E.g. process and value stream mapping, pareto, control charting, spaghetti diagram, root cause analysis, process and design (FMEA), project management; trained using DMAIC and PMO
◆ Quality Assurance Training, Change and Quality Risk Management Trainer (ICH Q9).
◆ Specialist in management of failure investigations (non-compliance); root cause analysis and CAPA
implementation.
◆ Production line management (quality inspection processes).
◆ Material handling expert, supply chain logistics, inventory management & planning, cold chain
management, sensitive commodity shipping & logistics.
◆ SAP PP, PI, MM, WM modules, Excel, Visio, PowerPoint literate
◆ Auditor (pharmaceutical and medical devices).
◆ 15 years’ experience in preparation and management of GMP license inspections by regulatory bodies
such as; MHRA (UK) and FDA (US).
Colin is skilled in risk analysis and management and has an:
◆ Abilitytodemonstrateinitiative,competentchangeagentforimprovementswithintheorganization, communication with stake holders at all levels.
◆ Proven skills – in development of risk-based training curricula including the formulation, development and presentation of training packages.
Professional Qualifications and Memberships:
◆ General Certificate in Occupational Safety and Health (National Examining Board in Occupational Safety & Health)
◆ Lean Six Sigma Green Belt
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