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Pharmaceutical quality management system (pqms) manager

Colchester (Essex)
East Suffolk and North Essex NHS Foundation Trust
Biostatistician
€42,500 a year
Posted: 11 May
Offer description

An exciting opportunity has arisen for a motivated and detail-oriented individual to join the MHRA‑licensed 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.


Responsibilities

* Give oversight to the QMS team and take a lead role in maintaining the Quality Management System (QMS), ensuring full compliance with GMP/GDP for all pharmaceutical licences held by the Trust.
* Support the Head of Pharmacy Quality Assurance and Quality Control in providing professional leadership to the pharmacy QA/QC department, ensuring continuing service development, cost‑effective operation, high standards, health and safety requirements, governance, risk management and product development within the Pharmacy Service.
* Provide Quality Assurance support for all preparative, wholesale and manufacturing activities 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 across both sites.
* Maintain the QMS in accordance with MHRA GMP/GDP requirements and continuously assess and enhance it to drive operational excellence and compliance per ICH Q10.
* Facilitate and coordinate management review of the QMS, ensuring senior leadership is informed of system performance.
* Develop and maintain key performance indicators (KPIs) to measure and report on QMS performance.
* Establish and maintain an effective document control system, ensuring all quality‑related documents are up‑to‑date, accessible, and compliant.


Benefits

* Generous pension scheme.
* Unsocial hours payments (where applicable).
* 27 days annual leave on commencement (pro rata).
* Access to a range of NHS discounts.
* Staff Health and Wellbeing programme offering a variety of services.
* Flexible working options.
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