Posted: 20 February
Offer description
Quality/RP Support
We are seeking a mature and experienced Quality Expert to join our small team responsible for Global Quality & Distribution.
This is a hybrid role with office space in Waterford City, offering part-time or full-time opportunities.
* Independently work on tasks, making risk-based quality decisions with confidence.
* Self-identify knowledge gaps and research solutions to ensure task progression.
* Organize tasks and ensure completion within the required timeframe.
The ideal candidate will be a team player who can adapt to a dynamic team environment where hierarchy shifts based on activities.
A strong understanding of EU GMP & GDP Requirements and guidance is essential.
Additionally, experience with MA content and MA compliance, as well as Change Control and Risk Review leadership, is required.
Requirements:
* 1 year of named RP experience on European WDA.
* Qualified QP certification.
* More than 10 years of Quality experience with expertise in writing and approving Change Controls, Deviations, Complaints, Risk Assessments, Auditing, and Quality System Management.
Role Details:
* 6-month contract to perform routine QA activities supporting MA Holder & WDA Holder responsibilities.
* Reports directly to the Associate Director of Quality & Compliance.
* Excellent working knowledge of EU GMP & GDP Requirements and guidance.
* Experience with regards to MA content and MA compliance.
* Leading Change Control Teams, executing and managing Change Controls, including impact assessment, action planning, and execution.
* Ensuring actions are progressed by the team for timely close-out.
* Working closely with QP, Operations, and Regulatory Affairs.
* Leading Risk Review teams, writing Risk Assessments, identifying risk, and mitigation solutions.
* Assessment and completion of Quality Defects', Deviations, root-cause analysis, and CAPA's.
* Supporting the transition from a paper-based system to eQMS; SOP updates, form creation, training facilitation.
