Qc Stability Specialist

A great opportunity to join a large and growing pharmaceutical company!
Responsibilities:Management of stability programs including generation of protocols and reports, sample management, compilation of results, and communication to both internal and external stakeholders.Trending and statistical analysis of stability and release data for quarterly reports and Periodic Product Reviews (PPRs).Raising and on-time closure of Stability, PQR, and trending related Quality System records including assigned Change Controls, Deviations, CAPAs, ILIs & QEs.Procedure effectiveness and simplification, actively contributing to continuous improvement initiatives utilizing lean methodologies where appropriate.Ensure effective co-ordination and support for external and internal audits for the department.Perform critical/constructive review of Stability, PQR, and trending related procedures and practices.Identify and lead projects to make step change improvements to the department's Quality.Conduct duties in a safe manner and report all safety issues or concerns.Support leadership team in achieving goals/tasks.Liaise with Quality Assurance Representative to support and improve RFT in the area and ensure the department is always audit ready.Ensure all required training is completed on time.Maintain training in critical test activities as required in the laboratory (will be defined by head of QC).
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