Denise Mc Gough
About Denise Mc Gough
Denise Mc Gough is a Team Lead at Alkermes in Athlone, County Roscommon, Ireland, with 29 years of experience in the pharmaceutical industry.
Current Company
Denise Mc Gough is currently working at Alkermes in Athlone, County Roscommon, Ireland. She holds the position of Team Lead, a role she has been in since February 2016.
Title and Responsibilities
As a Team Lead at Alkermes, Denise Mc Gough provides SME/Superuser support for laboratory systems, supports laboratory/IT investigations, and mentors new specialists. She also trains laboratory analysts on equipment qualification and their roles as Subject Matter Experts (SMEs). Additionally, she collaborates with QA, IT, Safety, and Maintenance teams when required.
Previous Roles
Denise Mc Gough has previously worked at Alkermes in several roles. From 2002 to 2014, she served as a Training Officer. Prior to that, she was a Laboratory Analyst from 1991 to 2002. Throughout these roles, she has amassed significant industry experience and knowledge.
Education and Expertise
Denise Mc Gough studied Chemistry at The Open University, where she achieved a Bachelor of Science (BS) degree. She has 29 years of experience in the pharmaceutical industry, with deep knowledge in cGMP, GAMP, 21 CFR, and EU Annex 11. Her expertise extends to validation of laboratory systems and equipment, as well as preparing qualification documentation from URS through IQ/OQ and PQ.
Project Management Experience
Denise Mc Gough acts as a project manager and technical lead for multiple laboratory instrument qualification projects that include software components. She is responsible for preparing and overseeing the qualification documentation and ensuring compliance with relevant regulations and standards.