About this role
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
Job description Job responsibilities
For full details of the responsibilities and duties of this role please see the attached job description.
Person Specification
Experience Essential
Previous extensive experience in a NHS licenced manufacturing unit or extensive experience in pharmaceutical industry which includes activities under the MS licence or MIA licence and MIA (IMP) licence. Demonstrated experience of multi-disciplinary working Previous experience in Radiopharmaceuticals Previous experience in managing a team Previous experience in performing root cause analysis using fishbone diagram and 5 Whys in a licenced unit Previous experience in GMP change management in a licenced unit.
Desirable
Previous experience of working as a Releasing Officer within MHRA licenced unit Previous experience of educating and training other staff Previous experience in WDA(H) activities Previous auditing experience
Qualifications Essential
Relevant pharmaceutical sciences degree or equivalent experience Registered with Royal Pharmaceutical Society or Royal Society of Chemistry or Royal Society of Biology
Desirable
Relevant postgraduate qualification White belt certified
Knowledge Essential
Extensive Knowledge of EU GMP/GDP and their application in pharmaceutical manufacturing Extensive knowledge in document control and data integrity Knowledge in QC Chemistry and QC Microbiology.
Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
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)