Quality/RP Support
We are seeking a seasoned Quality Expert to join our small team responsible for Global Quality & Distribution.
Key Responsibilities:
* Perform routine QA activities in support of MA Holder & WDA Holder responsibilities.
* Collaborate with the Associate Director of Quality & Compliance and other stakeholders to ensure seamless operations.
* Develop and implement effective quality systems, including Change Controls, Deviations, Complaints, Risk Assessments, Auditing, and Quality System Management.
* Lead Change Control Teams and Risk Review teams, writing risk assessments and identifying mitigation solutions.
* Assess and complete quality defects, deviations, root-cause analysis, and CAPAs.
* Support the transition from a paper-based system to an eQMS, including SOP updates, form creation, and training facilitation.
Requirements:
* 1 year named RP on European WDA.
* Qualified QP.
* More than 10 years of quality experience, with expertise in writing and approving Change Controls, Deviations, Complaints, Risk Assessments, Auditing, and Quality System Management.
Additional Information:
This is a hybrid role with office space in Waterford City. The ideal candidate will be able to work independently, make risk-based quality decisions, identify knowledge gaps, and research solutions to ensure continued progression of all tasks. The candidate should also be a team player who can fit into a dynamic team where each member takes lead on specific projects.