Job Summary

An exciting opportunity has arisen for a motivated and detail-oriented individual to join the MHRA licenced facilities at [Employer hidden — sign up to reveal]. 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.

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 [Employer hidden — sign up to reveal] 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.

Person Specification

Experience

• 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.

Qualifications

• Relevant pharmaceutical sciences degree or equivalent experience
• Registered with Royal Pharmaceutical Society or Royal Society of Chemistry or Royal Society of Biology

Knowledge

• 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.

Employer Details

Employer name: [Employer hidden — sign up to reveal]

Address: Colchester Hospital, Turner Road, Colchester, CO4 5JL

Employer's website: [Employer hidden — sign up to reveal]

Contact Details

For questions about the job, contact: Head of Quality Assurance, Mina Tawfik - [Employer hidden — sign up to reveal], [contact hidden]