Aimee Goulding
About Aimee Goulding
Aimee Goulding is a QA Specialist in IT and CSV at MeiraGTx, with a background in Biomedical Science from the University of Surrey. She has extensive experience in quality assurance roles across various organizations and possesses strong knowledge of regulatory guidelines.
Current Role at MeiraGTx
Aimee Goulding currently serves as a QA Specialist, IT & CSV at MeiraGTx, a position she has held since 2018. In this role, she focuses on quality assurance processes related to computerized systems and CSV (Computer System Validation). Her responsibilities include ensuring compliance with regulatory standards and implementing best practices in quality management within the organization.
Previous Experience at MeiraGTx
Before her current role, Aimee worked at MeiraGTx as a QA Documentation Controller from 2017 to 2018. During this time, she was involved in managing quality assurance documentation and ensuring adherence to established protocols. This experience contributed to her understanding of quality systems within the biotechnology sector.
Education and Qualifications
Aimee Goulding earned her BSc (Hons) in Biomedical Science from the University of Surrey, studying from 2009 to 2013. Prior to this, she completed her A Levels in Mathematics, Biology, and Chemistry at Palmers College from 2007 to 2009. She also achieved 14 GCSEs (A*-B) at Hassenbrook Specialist Technology College, which included subjects such as English, Mathematics, and Science.
Quality Assurance Experience
Aimee has extensive experience in quality assurance roles across various organizations. She worked as a Quality Assurance Administrator at Retroscreen Virology Group plc from 2014 to 2015, and as a Quality Assurance Associate at Norgine from 2015 to 2017. Her roles involved implementing and maintaining quality systems, authoring standard operating procedures (SOPs), and managing risk-based validation strategies.
Technical Expertise
Aimee Goulding possesses a strong working knowledge of regulatory frameworks and guidelines, including EU Annex 11, 21 CFR 11, ISPE GAMP5, ISPE Data Integrity, and ICH Q9. Her expertise includes developing risk-based strategies for validation and data governance, as well as managing the lifecycle of computerized systems, which encompasses training, change management, and incident management.