Quality/RP Support
Looking for a mature and experienced Quality Expert to work within a small team who are responsible for Global Quality & Distribution.
Hybrid role with office space in Waterford City.
Would suit someone looking for Part-time or Full-time role.
Ideal candidate can work independently, is confident making risk-based quality decisions, can self-identify knowledge gaps and research to find the answers to ensure continued progression of all tasks.
A Team player who can fit into a dynamic team where each member takes lead on specific projects so the hierarchy can shift based on activities.
Ability to organise tasks and ensure all tasks are fully completed.
Fluent English with excellent communication and report writing skills is a pre-requisite.
Minimum Requirements
· 1 year named RP on European WDA.
· Qualified QP.
· >10 years Quality experience with expertise in the writing and approval of Change Controls, Deviations, Complaints, Risk Assessments, Auditing, Quality System Management.
Role Detail:
· 6-month contract to perform routine QA activities to support MA Holder & WDA Holder responsibilities.
· Reports to 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, both execution and management of Change Controls, including impact assessment, action planning and execution.
o Ensuring actions are progressed by team for timely close out.
o 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 & CAPA's.
· Support transition from paper-based system to eQMS; SOP updates, form creation, training facilitation.
For more information and a confidential chat, feel free to reach out to me on [email protected] or call me on 01-482 5494
