During my time in this role the site has had three different owners; in order they are UCB Manufacturing Ireland Limited, Avara Shannon Pharmaceutical Services Limited and currently Eirchem Pharma Services Limited.I have worked as a production supervisor in two different FDA regulated plants, an API manufacturing plant and a bulk drug substance plant. I was responsible for the management of a team of 4 Chemical Process Operators, to achieve Safety, Quality and WIP targets. I also provided frontline technical expertise covering processing, equipment, automation and compliance for these plants.I was also a key team member involved in the Commissioning, Qualification and Start-up of upgrades to the API manufacturing facility and the subsequent Validation of multi-step API manufacturing and cleaning processes.As a certified Green Belt I have lead or been a member of Continuous Improvement projects using 6-Sigma or 5-S methodologies.Finally I was responsible for the safe and compliant cleaning and wind up of both plants in preparation for the closure of the site.

In this role I was responsible for providing frontline technical support to the Operations Department for a multi-step process in an automated API manufacturing plant. I was also responsible for the receipt of technology transfer of a new API manufacturing process to site and and prepare for transfer to plant.I also lead the upgrade of a Kilo Plant facility from non GMP to a GMP compliant state and the subsequent manufacture of API under GMP conditions in that Plant.

As operations chemist I provided frontline technical support to the Operations Dept. for a multi-step process in an API manufacturing plant running DeltaV automation ensuring effective problem solving and decision making to ensure schedules are achieved, Deviations investigated, and Corrective/ Preventive actions closed in the shortest time possible. I also prepared and reviewed technical documentation and automation recipes for manufacturing and cleaning. I was part of a cross-functional team that delivered the Commissioning, Qualification and Start-up of a refitted API manufacturing facility.As cover supervisor I provided holiday cover for production supervisors entailing management of the daily activities of a team of 7 process operators to achieve Safety, Quality and WIP targets in a dynamic, challenging and FDA regulated environment.

As Chemistry Team Leader I managed a team of 5 process chemists with responsibility for development, improvement and support of several API manufacturing processes within an FDA regulated environment.I lead an interdepartmental team at Shannon site in the validation and filing of a multi-step API manufacturing process. I was a member of the CMC sub team with responsibility for technical aspects of an API manufacturing process at multiple sites in Europe and Japan. I coordinated technology transfers to several manufacturing sites, providing production support, documentation review and deviation management at these sites.

As senior development chemist I was the Project lead for laboratory development and scale-up of a multi-step API manufacturing process. I also provided technical support to the production Dept for the API manufacturing process and trained production personnel.