Paul Fitzgerald
About Paul Fitzgerald
Paul Fitzgerald is currently the MES QA Lead at Bristol-Myers Squibb in County Dublin, Ireland, with extensive experience in quality assurance, compliance, and validation within the pharmaceutical industry.
Current Role at Bristol-Myers Squibb
Paul Fitzgerald currently holds the position of MES QA Lead at Bristol-Myers Squibb in County Dublin, Ireland. In this role, he is responsible for ensuring compliance and quality assurance within the Manufacturing Execution System (MES). In addition, Paul also serves as a QA CSV Specialist at the Bristol-Myers Squibb facility in Cruiserath, Mulhuddart, Dublin 15, where he focuses on Computer System Validation (CSV). His dual roles exemplify his capability to manage complex quality assurance tasks in a pharmaceutical setting.
Previous Experience at MSD
Paul Fitzgerald has a robust history with MSD, having worked there from 2009 to 2017. He started as an Automation Validation Engineer and held this position for seven years in Swords, Co. Dublin, Ireland. Subsequently, he advanced to the role of CSV Lead, where he worked for an additional year. During his tenure at MSD, Paul accrued valuable experience in computer system validation, project management, and compliance within the pharmaceutical industry.
Early Career in Control Systems Engineering
Before joining MSD, Paul Fitzgerald accumulated significant experience in control systems engineering. From 2007 to 2009, he was employed at Schering-Plough as a Control Systems Engineer in Swords, Co. Dublin, Ireland. Prior to that, he held a similar role at Organon Ireland Limited from 1999 to 2007. Paul's early career also includes a brief stint at MJM Electronics in 1997, where he worked in Nenagh, Co. Tipperary, Ireland.
Educational Background
Paul Fitzgerald's academic credentials include a Postgraduate Diploma in Industrial Physics from the University of Limerick, achieved between 1998 and 1999. Prior to that, he studied Physics and Maths at University College Dublin, obtaining a Science degree over a span of three years, from 1995 to 1998. His educational foundation in physics and mathematics provides him with the analytical skills necessary for his roles in quality assurance and validation.
Expertise and Training
Paul Fitzgerald has extensive in-house training in various regulatory and compliance frameworks, including GxP, GAMP5, FDA Guidelines & 21 CFR part 11, Change Control, Deviations (Investigations and CAPAs), and Standard Operating Procedures (SOPs). His expertise extends to managing projects, validation, compliance, Lean Six Sigma (LSS), and auditing. Known for his coaching style in team development, Paul has also gained multinational exposure to different organizational structures and commercial priorities.