Do you have extensive GMP hospital or industrial experience and are looking for your next step in your career at an acute hospital trust? Is so, we have the role for you.

Due to the expansion of our current product manufacturing service we have a new exciting role as a Senior Quality Assurance/Quality Control Specialist to join our Pharmacy Quality Assurance Department at East Suffolk and North Essex NHS Foundation. You will be based at Colchester Hospital, however you will be required to work across at Ipswich Hospital.

You will provide project management for our electronic pharmaceutical quality system. In additional you will have oversite of the QA/QC Officers and as you develop in the role you will then have line management of the team.

This is the ideal opportunity if you are looking to develop your knowledge and experience at a senior level within ESNEFT.

You will need good planning and organisational skills and must be able to demonstrate excellent communication.

Main duties of the job

• To support the Quality Management System and Operations Lead in setting up new products manufactured under MHRA MS Licence.
• To work collaboratively with the Production team in processing and closing out in a timely manner different QMS records such as Deviations, Corrective and Preventative actions (CAPAs) and Change Controls.
• To provide Quality Assurance support for all preparative and manufacturing activity taking place within the Technical Services department of the Pharmacy Service.
• To support the Quality Management System and Operations Lead in ensuring all aspects of Quality Assurance activity are carried out in according with Good Manufacturing Practice and in line with all requirements set out by the MHRA.
• To release manufactured products under the MHRA MS licence..
• To release unlicensed medicines as per the department procedures.
• To be the authorised releasing officer for batches as well as named patient manufactured products.

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 GMP hospital experience (inclusive of Pharmacy Technical Services practice as required by MHRA guidance for specials manufactures for batch release) or extensive experience in pharmaceutical industry.
• Previous extensive experience in Pharmaceutical QMS
• Handling of high risk medicines
• Demonstrated experience of multi- disciplinary working

Desirable

• Previous experience of sterile manufacturing
• Previous experience in Radiopharmaceuticals

Qualifications

Essential

• Degree in Pharmaceutical Science, Pharmacy, Biotechnology or equivalent science degree/certificate

Desirable

• Member of Royal Pharmaceutical Society, or Royal Society of Chemistry or Royal Society of Biology
• Postgraduate Diploma in Pharmaceutical Science or equivalent
• White belt certified or equivalent

Knowledge

Essential

• Computer Literacy
• Intermediate/professional user of Microsoft 365
• Strong knowledge of cGMP/GLP, Pharmaceutical Quality Assurance and all current legislations and regulations
• Strong knowledge in Cytotoxic, CIVAS and Radiopharmaceutical manufactured products
• Knowledge of laboratory and production facilities SOPs and ability to revise and write new SOPs
• Strong knowledge of risk management, deviations, investigations and CAPAs
• Understand the principles of ALCOA plus

Desirable

• Knowledge of legislation relating to the manufacture and distribution of human medicines
• Good clinical knowledge

Employer details

Employer name

East Suffolk and North Essex NHS Foundation Trust

Address

Colchester Hospital

Turner Road

Colchester

CO4 5JL

Any attachments will be accessible after you click to apply.

432-HR974-24