Quality/RP Support
A seasoned Quality Expert is sought to join a small team focused on Global Quality & Distribution.
This hybrid role offers office space in Waterford City and can be tailored to suit either part-time or full-time work arrangements.
The ideal candidate will be an independent worker with confidence in making risk-based quality decisions, able to identify knowledge gaps and research solutions to drive task progression.
A team player who can adapt to a dynamic environment where each member takes the lead on specific projects, requiring flexibility in their approach.
Key responsibilities include organizing tasks, ensuring completion, and maintaining excellent communication and report writing skills in fluent English.
Minimum Requirements:
* 1 year named RP experience on European WDA.
* Qualified QP.
* More than 10 years of Quality experience, with expertise in Change Controls, Deviations, Complaints, Risk Assessments, Auditing, Quality System Management.
Role Detail:
The selected candidate will undertake routine QA activities to support MA Holder & WDA Holder responsibilities under a 6-month contract. Direct reporting will be to the Associate Director of Quality & Compliance.
The successful individual will possess an excellent working knowledge of EU GMP & GDP Requirements and guidance, as well as experience regarding MA content and compliance.
Responsibilities will include leading Change Control Teams, managing Change Controls, and ensuring timely close out by the team. Close collaboration will be required with QP, Operations, and Regulatory Affairs teams.
Ongoing duties will also involve leading Risk Review teams, writing Risk Assessments, identifying risks and mitigation solutions, assessing and completing Quality Defects, Deviations, root-cause analysis & CAPA's, and supporting the transition from a paper-based system to eQMS, including SOP updates, form creation, and training facilitation.
For more information and a confidential discussion, please reach out.