Wayne Steele Email & Phone Number

Location: Cheshire | North West PCQI | Cogent RP Gold Standard | IRCA Lead Auditor | IEMA | NEBOSHAward winning Head of Quality & RP - Winner of Movianto UK & Walden European Client Centric Award. Lead the UK Quality team as Head of Quality and RP, ensuring the effective implementation, management and review of the company’s Quality Management System. Ensuring continued compliance to GDP, GMP requirements and ISO 9001, ISO 13485 and ISO 14001 (working on ISO 27001)Provide competant Quality advice and guidance to the business and clients, improving performance and ensuring continued compliance within the business. Work with UK clients on the release of pharmaceutical products into the UK market. Quality Project Lead and SME on Govt and Manufacturer Projects for Covid Vaccine supply chain within the UK and Worldwide.RP/QC approving release of thaw and labelled packaging processes under WDA (H) and MIA.Technical Agreement writing, review and approval. DIOP Qualification & Validation on storage and shipping solutions (passive and active) for; -75 ULT, -40, -25, -20, Chill and ATC Warehousing and Transportation.Facilitate compliance inspections and audits from external regulatory bodies and leading pharmaceutical manufacturers/clients. Auditing - Self Inspections, internal audits, Supplier Auditing and reporting. Advise and lead continuous improvement within the Group.Approval of SOP, Work Instructions within the Quality Management System for GDP and GMP processes. Work with all levels of internal and external stakeholders Group Management structure enabling them to fulfill their Quality responsibilities.Approve and deliver training to all levels of employees across the Group in areas of Compliance. Extensive experience in; Quality, Safety and Environmental Management Systems.Risk Management.Deviation investigation, root cause analysis and CAPA implementation and review. Change ManagementATC, Frozen and Cold Chain Distribution. Vaccine and Covid vaccine receipt, storage and distribution. GMP PI repackaging and thaw and label processes. Quality, Safety, Environmental and Fire Risk Assessment. (IEMA, NEBOSH OHS & Fire Safety)Accident/incident investigation and reporting. EL/PL claim reviews and effective communication with external insurance companies and solicitors. Safety Training - IOSH approved trainer for Managing Safely. 5S in a manufacturing environment.Lean Management (Warehouse Excellence) pharmaceutical wholesale distribution in the UK and within Europe.CV available upon request.

Listed skills include Quality System, Continuous Improvement, Environmental Awareness, Manufacturing, and 11 others.