Robert Walter Email & Phone Number

From an early age I enjoyed taking thing apart and reassembling them. This grew into building knowledge of how things were made and worked. I have used this knowledge in my professional life to develop products and manufacturing processes from initial conceptual designs to successful manufacturing operations.In recent years I have worked in a highly regulated industry that supplies medical devices which are used worldwide.Used a systematic approach to manage development stages which resulted in successful output of fully validated, qualified and regulatory approved products (FDA and CE marked) being commercially produced.Developed, justified and raised capital vouchers for expenditure on new pilot and production plants.Identified new suppliers, carried out supplier audits, placed orders and obtained delivery when required, signed off invoices.Organised, participated in and issued Hazard Studies.Carried out Integrated Risk Assessments and Process Safety ReviewsAware of Dangerous Substances and Explosive Atmosphere Regulation (DSEAR)Carried out initial commissioning trials on newly installed manufacturing plantsResolved scale up issues during installation and development of new and existing products.Planned and carried out process optimisation / design of experiments (DoE) and process capability studies resulting in product that meet specification.Taken responsibility for process qualification / validation studies (URS, MVP, IQ, OQ and PQ)Developed, wrote and issued robust standard operating procedures.Carried out training of technicians and operativesProduced on-going trend analysis using control charts created using Minitab software.Carried out CAPA investigation identifying root causes using tools such as fish-bone (Ishikawa diagram) and 5-whys. Instigated and carried out change control projectsParticipated in a number of product and process risk management projectsHave knowledge of ISO EN BS 13485, 10993, 11137, 14971 and 6001; also FDA 510k submissions and technical input to CTD documentation for CE mark submissions.

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  University Of Wolverhampton

  Applied Chemistry