Job Summary:
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This role is responsible for the management of stability programs, including the generation of protocols and reports, sample management, compilation of results, and communication with internal and external stakeholders.
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Key Responsibilities:
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* Trending and statistical analysis of stability and release data for quarterly reports and Periodic Product Reviews (PPRs).
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* Raising and timely closure of Stability, PQR and trending related Quality System records, including assigned Change Controls, Deviations, CAPAs, ILIs & QEs.
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* Procedure effectiveness and simplification, contributing to continuous improvement initiatives using lean methodologies where appropriate.
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* Effective coordination and support for external and internal audits for the department, performing critical/constructive review of Stability, PQR and trending related procedures and practices.
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* Identifying and leading projects to make step-change improvements to the department's Quality.
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* Conducting duties in a safe manner and reporting all safety issues or concerns.
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Requirements:
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A third-level qualification in a scientific/technical discipline is required. Two to three years of experience are also necessary.
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What We Offer:
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The successful candidate will be part of a dynamic team working on challenging projects. They will have the opportunity to develop their skills and expertise in a supportive environment.