Job Title: Quality/RP Support
We are seeking a seasoned and experienced Quality Expert to join our small team responsible for Global Quality & Distribution.
Key Responsibilities:
* Perform routine QA activities to support MA Holder & WDA Holder responsibilities within a 6-month contract.
* Report directly to the Associate Director of Quality & Compliance.
* Provide an excellent working knowledge of EU GMP & GDP Requirements and guidance.
* Lead Change Control Teams, including execution and management of Change Controls, impact assessment, action planning, and execution.
* Ensure timely close-out of actions progressed by the team.
* Collaborate closely with QP, Operations, and Regulatory Affairs teams.
* Lead Risk Review teams, writing Risk Assessments, identifying risks, and mitigation solutions.
* Assess and complete Quality Defects, Deviations, root-cause analysis, and CAPA's.
* Support the transition from a paper-based system to eQMS, including SOP updates, form creation, and training facilitation.
Requirements:
* 1 year named RP on European WDA.
* Qualified QP.
* >10 years Quality experience with expertise in writing and approval of Change Controls, Deviations, Complaints, Risk Assessments, Auditing, Quality System Management.
ideal Candidate:
A mature and experienced professional who can work independently, make risk-based quality decisions, self-identify knowledge gaps, and research to find answers to ensure continued progression of tasks. The ideal candidate should be confident, self-motivated, and able to take the lead on specific projects within a dynamic team environment.
Working Arrangements:
This is a hybrid role with office space in Waterford City, suitable for both part-time and full-time candidates.
Skills Required:
* Fluent English with excellent communication and report writing skills.