Ensuring quality is at the heart of our operations. We have a strong focus on compliance and continuous improvement.
About This Role
This position works within a multi-disciplinary team to design, implement, and maintain processes that guarantee consistency and adherence to regulatory standards.
This is an onsite role based in Dublin, Ireland.
Responsibilities
* Provide subject matter expertise for facility operations, ensuring seamless execution of business activities.
* Promote quality awareness throughout the organization, supporting the development of a culture that values excellence.
* Maintain effective governance processes for site compliance to the Pharmaceutical Quality System (PQS).
* Participate in PQS performance reviews and provide regular reporting, highlighting areas for improvement.
* Execute a comprehensive internal audit programme and propose enhancements to improve overall quality.
* Monitor and coordinate completion of GxP Audit PQS records, ensuring accuracy and timeliness.
* Offer compliance support by advising on and escalating issues related to regulatory requirements.
* Collaborate with other elements of the Quality Management System (QMS) and QA team to ensure site compliance and achievement of business KPIs.
* Administer the Quality Management System and act as a QA Archivist, maintaining accurate and up-to-date records.
Required Skills and Qualifications
* Bachelor's degree or equivalent in a scientific discipline.
* Understanding of Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs), with a focus on regulatory compliance.
* Ability to manage multiple tasks and prioritize workload effectively, with attention to detail and analytical skills.
* Quality experience working within a regulated environment, preferably in a GMP setting.