Emma Beirne
About Emma Beirne
Emma Beirne is an OSD-QA Specialist and QP (in training) at Alkermes in Athlone, County Roscommon, Ireland, with extensive experience in quality assurance and compliance in the pharmaceutical industry.
Current Role at Alkermes
Emma Beirne currently holds the position of OSD- QA Specialist/QP (in training) at Alkermes in Athlone, County Roscommon, Ireland. In this role, she leads investigations, product impact analysis, and risk assessments related to deviations and customer complaints, ensuring the timely implementation of appropriate actions. She also provides compliance direction at Product Review Boards, assisting in the resolution of issues across multi-functional departments.
Previous Experience at Aerie Pharmaceuticals
From 2019 to 2021, Emma Beirne worked at Aerie Pharmaceuticals as a Sterile Manufacturing - QA Specialist in County Westmeath, Ireland. During her tenure, she was responsible for ensuring quality assurance in sterile manufacturing processes, demonstrating her expertise in maintaining high standards within pharmaceutical manufacturing environments.
Career at Allergan
Emma Beirne served as a Sterile Manufacturing/Biologics - Senior Quality Compliance Analyst at Allergan, County Mayo, Ireland from 2017 to 2019. In this role, she provided significant contributions to quality compliance in sterile manufacturing and biologics, ensuring adherence to strict regulatory requirements and maintaining product quality.
Educational Background
Emma Beirne has a robust educational background in fields related to quality assurance and pharmaceuticals. She received a Bachelor's degree in Biomedical Science from the National University of Ireland, Galway (2007-2011). She earned a Master's of Industrial Science from the Institute of Technology, Sligo (2016-2018) with a focus on QP studies. Additionally, she holds a certificate in Auditing (Pharmaceuticals) from University College Cork (2019) and completed a Diploma in Leadership and Management at University College Dublin in 2021.
Expertise in Quality Systems
Emma Beirne has demonstrated proficiency in using several Quality Systems including Trackwise, Trackwise DIG, SAP, PAS-X e BR, and Veeva. Her experience with these systems showcases her ability to manage and ensure compliance within quality assurance processes effectively.