Quality/RP Support
We are seeking an experienced Quality Expert to join our small team responsible for Global Quality & Distribution.
Key Responsibilities:
* Work independently with confidence in making risk-based quality decisions.
* Self-identify knowledge gaps and research to find answers to ensure continued task progression.
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.
Role Details:
* 6-month contract to perform routine QA activities supporting MA Holder & WDA Holder responsibilities.
* Reports to Associate Director of Quality & Compliance.
* Excellent working knowledge of EU GMP & GDP Requirements and guidance.
* Experience with MA content and MA compliance.
* Leading Change Control Teams, including execution and management of Change Controls, 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 CAPAs.
* Supporting the transition from a paper-based system to eQMS, SOP updates, form creation, training facilitation.