Quality Management System (QMS) Manager

Job summary

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.

About us

We are ESNEFT and we provide hospital and community health services to almost one million people across east Suffolk and north Essex. Our dedicated staff deliver care from acute hospitals in Colchester and Ipswich, community hospitals, surgeries, community clinics and in patients' own homes.

We are one of the largest NHS organisations in England, employing more than 12,000 staff.

We pride ourselves on supporting our staff. We offer a wide range of training and development opportunities, as well as flexible working options.

Along with supporting you to achieve your career goals we offer a generous pension scheme, unsocial hours payments (where applicable), 27 days annual leave on commencement (pro rata) and access to a range of NHS discounts. Our Staff Health and Wellbeing programme offer a variety of services.

Our philosophy is that Time Matters to everyone. Across the Trust, we concentrate on improving the things we do and removing those which cause time delays for our staff and patients.

We are investing in our commitment to Time Matters with a partnership with leading electronic patient record (EPR) supplier Epic. This digital transformation will bring what's widely regarded as the world's best EPR system to ESNEFT, transforming life in hospital for staff and patients.

If you are passionate about patient care and want to develop your skills and knowledge, then we want to hear from you.

Find out about living and working here - www.youtube.com/watch?v=GkPu7HphU8A

Employer details

Employer name

East Suffolk and North Essex NHS Foundation Trust

Address

Colchester Hospital

Turner Road

Colchester

CO4 5JL

Employer's website

https://www.esneft.nhs.uk/ (Opens in a new tab)

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Employer details

Employer name

East Suffolk and North Essex NHS Foundation Trust

Address

Colchester Hospital

Turner Road

Colchester

CO4 5JL

Employer's website

https://www.esneft.nhs.uk/ (Opens in a new tab)

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