Quality Assurance / Quality Control Specialist Technician

NHS; Exeter; On-site; GBP 30,000 - 50,000

Job description

Quality Assurance / Quality Control Specialist Technician

Royal Devon University Healthcare NHS Foundation Trust

Are you looking for a unique opportunity to develop and manage an electronic Pharmaceutical Quality Management System?

The Royal Devon University Healthcare NHS Foundation Trust has a vacancy for a new post to manage and support the development of the quality management system. We are currently using the Ideagen Quality Management system. The Aseptic unit will be applying for a Manufacturing Specials (MS) licence in 2026 and require development of the current system. Experience in Pharmacy Technical Services or the pharmaceutical industry and a good knowledge of current Good Manufacturing Practice (cGMP) and regulatory requirements are essential for this role.

Main duties of the job

As a key member of the Royal Devon University Healthcare NHS Foundation Trust, you will be joining an exceptional team working together to help our patients to stay healthy, when they need it most.

Job responsibilities

This is a fixed term contract for 23 months. The post holder will be embedded into the Pharmacy Quality Assurance/Quality Control Team. As a key member of the Trust, you'll be joining an exceptional team working together to help our patients when they need it most.

Responsibilities include:

• The maintenance of the electronic Quality Management System (eQMS) across Pharmacy Technical Services.
• Leading on the scheduling and delivery of internal audits.
• Addressing internal and external audit findings and self-inspection findings and supporting others to do likewise.
• Acting as Quality Reviewer and Departmental Manager to review records on the electronic Quality Management System (eQMS) including performing and reviewing impact and risk assessments, review of action plans and review for closure.
• Completing your assigned actions on the eQMS.
• Raising and reviewing records and action plans on the eQMS including audits, exceptions/deviations, out of specification results, complaints and capacity issues in line with local procedures.
• Review of records on the eQMS for closure.
• Any other activities involved in the maintenance of the QMS.
• Driving continuous improvement and promote a culture of quality across all Pharmacy Technical services.
• Write and approve validation protocols and reports.
• Complete validation protocols and reports.
• Review of environmental monitoring data to identify trends and ensuring these are logged on the eQMS.
• Participate in the department rota to ensure a pharmacy service is provided efficiently over 7 days including weekends, late duties and bank holidays.

Person Specification

Qualifications / Professional Registration

• Hours level Degree in Pharmacy, Chemistry, Biology, or a related scientific field or equivalent experience.
• Or Basic qualification in pharmaceutical sciences (BTEC) or an equivalent scientific qualification to same level with a Postgraduate Diploma in Pharmaceutical Technology or similar.
• Eligible to be registered with the General Pharmaceutical Council (GPhC), Health and Care Professions Council (HCPC), Royal Society for Chemistry (RSC) or Royal Society for Biology (RSB) or Royal Pharmaceutical Society (RPS).
• Post-graduate certificate or diploma in relevant field or equivalent knowledge.
• Master Qualification in a scientific discipline (preferably in Pharmaceutical Manufacture) or be willing to work towards a Diploma / Master's degree while in post.

Experience and knowledge

• Aseptic preparation and Good Manufacturing practice.
• Experience of training others.
• Accuracy checking training.
• Customer care.
• Good dispensing, distribution, manufacturing practice.
• Incident and error reporting.
• Experience and knowledge of pharmaceutical Quality Management Systems.
• Experience and knowledge of regulatory guidance and standards relating to pharmaceutical quality management (e.g. GMP, GDP and ICH Q10).
• Experience and knowledge of risk management.
• Experience in supporting change management.
• Knowledge of clean room design and functioning.
• Managing change.
• Health & Safety / COSHH assessments.
• Project management.
• Experience in audit.
• Experience in training and presenting.
• Hospital pharmaceutical QA/QC and/or manufacturing/aseptic preparation service experience.

Working Pattern: 37.5 per week Monday to Friday 08:30am - 17:00pm and weekend working approximately one weekend in six.

Interview date: Monday 28th April 2025. Please note that you will be notified via email regarding the result of your application.

For further details please contact: Paul Lobb, Pharmacy Quality Assurance Manager, on [e-mail] or by telephone [phone].

As an inclusive employer, the Royal Devon values diversity and is committed to creating a culture of inclusivity where everyone can be themselves and reach their full potential. We believe in fostering a sense of belonging and actively encourage applications from individuals of all backgrounds, cultures, and abilities.

Preference will be given to staff with Priority and 'At Risk' status including NHS At Risk staff throughout Devon.

The Royal Devon University Healthcare NHS Foundation Trust reserves the right to close vacancy when sufficient applications have been received.

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 name: Royal Devon University Healthcare NHS Foundation Trust