[ref. l91223618] Quality Assurance Officer - Seaton Delaval
To support and maintain the Pharmaceutical Quality System (PQS) within theMedicines Manufacturing Centre (MMC), ensuring compliance with Good Manufacturing Practice (GMP), NHS guidance, and MHRA regulations. To complete relevant aspects of the PQS reporting systems e.g. Documentation Control, revision and approval, Change Control, Deviations, Quality RiskAssessments, Root Cause Analysis, Micro non-conformances, Complaints, Supplier Approval, Key Performance Indicator Trending, Quality Technical Agreements and Training Processes.
To co-ordinate and perform the review, approval, and monitoring of QA processes, documentation, and release of products, as well as ensuring continuous improvement and regulatory compliance. To participate on investigations involving the quality of pharmaceutical products across the MMC To manage the Quality Assurance staff during day-to-day operations and longer-term planning To plan and implement a strategy to ensure a robust and fit for purpose Quality Assurance workforce throughout the product lifecycle To develop and monitor quality KPIs which demonstrate the state of control of the facility, and report these to the senior management team To role model compassionate and inclusive leadership to shape the creation of a collective leadership culture within the Trust.This means demonstrating a consistent leadership style which (a) engages, enables and empowers others (b) uses coaching to promote ownership of learning and quality improvement and (c)facilitates team working and collaboration within teams / departments and across organisational boundaries.