QA Specialist & Responsible Person - Hybrid Role in Dublin

In this role, I support the Quality team in maintaining our organisation's Quality Management System (QMS) and ensure compliance with ISO 9001, GMP, and GDP standards, along with our internal procedures. My responsibilities include raising non-conformances, deviations, and change requests while meticulously maintaining all trackers. I manage the supplier controls system, including evaluations and assessments, analyse process performance, and prepare presentations for Quality Management review meetings. Conducting internal audits to ensure adherence to our audit schedules is a key duty, as well as driving continual improvement initiatives and maintaining our internal KPIs. I communicate changes to the QMS effectively to team members. As the Responsible Person, I ensure compliance with GDP and EU/HPRA guidelines while upholding the conditions of the Wholesale Distribution Authorisation. I conduct timely bona fides evaluations of suppliers and customers and oversee self-inspections and audits according to our audit schedule. Additionally, I serve as the primary contact for the HPRA, ensuring that any changes in facilities or products are reported promptly, always prioritising patient and product safety.