Pharmaceutical Quality Management System (PQMS) Manager
East Suffolk and North Essex NHS Foundation TrustAlready thinking ahead to interview?
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Job overview
An exciting opportunity has arisen for a motivated and detail-oriented individual to join the MHRA licenced facilities at East Suffolk and North Essex NHS Trust. You will support the manufacture of specials, wholesale dealing operations and management of investigational medicinal products used in clinical trials and specialist patient treatments. In addition you will give oversight to the QMS team and taking a lead role in maintaining the Quality Management System (QMS) and ensuring full compliance with the regulatory requirements (GMP/GDP) for all pharmaceutical licences held by the Trust.
You will support the Head of Pharmacy Quality Assurance and Quality Control in providing the professional leadership to the pharmacy QA/QC department ensuring continuing service development (Quality systems), cost effective operation, the maintenance of the high standards commensurate with the licences and health and safety requirements, and an appropriate focus on governance, GMP/GDP compliance, safety, risk management and product development within the Pharmacy Service. The post holder will be based at Colchester Hospital but this role will involve cross-site activity at Ipswich Hospital on a regular basis.
Main duties of the job
Provide Quality Assurance support for all preparative, wholesale and manufacturing activities taking place within the Technical Services department of Pharmacy at ESNEFT
Lead and mentor the QMS team, providing direction, guidance, and support, fostering a culture of quality and compliance within the team and across both sites.
Maintain the QMS in accordance with MHRA GMP/GDP requirements. Continuously assess and enhance the QMS to drive operational excellence and compliance as per ICH Q10.
Facilitate and coordinate management review of the QMS, ensuring that senior leadership is informed of the system's performance. Develop and maintain key performance indicators (KPIs) to measure and report on QMS performance
Establish and maintain an effective document control system, ensuring that all quality-related documents are up-to-date, accessible, and compliant.
Detailed job description and main responsibilities
For full details of the responsibilities and duties of this role please see the attached job description.