The Quality Specialist Dublin is responsible for supporting the manufacture of product at Manufacturing Organisation (CMO) sites, under the management of Quality Operations. The role involves ensuring products are evaluated and any issues are investigated for the preparation for QP release for products manufactured by the companies CMO’s and to undertake activities relating to processes, systems and supporting activities.

Principal Duties and Responsibilities

• Foster and promote GMP, GDP and the associated Quality Management Systems within the site
• Review Finished Batch Record and GMP Release for final QP Release
• Support ongoing preparation for Regulatory and Client audits, ensuring timely audit response and completion of agreed actions on time
• Oversee and input to CMO related Change Control, Non-conformance and CAPA activities; ensuring appropriate training of team as required
• Enhance and develop Quality Management System activities associated with the release of CMO product, integrating as appropriate into central activities
• Integrate with the QEHS and Compliance group on audit activities ensuring an adequate program executing audits as required.
• Ensure appropriate maintenance of filing of CMO related documents
• Implement and ensure correct usage of appropriate Database(s) for the support CMO Activities.
• Coordinate and support the control of Product Manufacturing activities
• Undertake tasks as assigned by line Manager

• Primary Qualification in Science, Engineering or related discipline
• Quality Management experience 3 – 5 years minimum;
• Experience working in a GMP environment
• Regulatory experience desirable

• Full-time, permanent role
• Available to work beyond normal office hours and weekends