Quality Assurance / Quality Control Specialist Technician

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Quality Assurance / Quality Control Specialist Technician, Exeter

Client:

Royal Devon and Exeter NHS Foundation Trust

Location:

Exeter, United Kingdom

Job Category:

Other

EU work permit required:

Yes

Job Reference:

c5a21395d697

Job Views:

3

Posted:

26.03.2025

Expiry Date:

10.05.2025

Job Description:

Role Summary

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 6 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.

About the Role

This is a fixed term contract for months. This post provides a unique opportunity to join the pharmacy team at the Royal Devon University Healthcare NHS Foundation Trust based at the Royal Devon and Exeter Hospital (Wonford) in Exeter. Previous experience with computerised quality management systems particularly Q-Pulse /Ideagen Quality Management would be an advantage. Good general computer skills and knowledge are essential for this role and the ability to teach staff with less computer experience how to use the system.

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.

Job responsibilities

• To support in order to ensure continued compliance to regulatory standards - Good Manufacturing Practice (GMP) related to Pharmacy Technical Services (Technical Service Unit (TSU), Exeter Pharmaceutical Services (EPS), Radiopharmacy (RP) and Quality Assurance (QA)).
• 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 GMP, GDP and ICH Q).
• Experience and knowledge of risk management.
• Experience in supporting change management.
• Knowledge of clean room design and functioning.
• Managing change.
• Incident and error reporting.
• 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 per week – Monday to Friday: am – :pm and weekend working approximately one weekend in six.

Interview date: Monday

For further details please contact: Paul Lobb, Pharmacy Quality Assurance Manager.

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.

The Royal Devon University Healthcare NHS Foundation Trust was established in April 2, bringing together the expertise of both the Royal Devon and Exeter NHS Foundation Trust and Northern Devon Healthcare NHS Trust.

About Us

Stretching across Northern, Eastern and Mid Devon, we have a workforce of over , staff, making us the largest employer in Devon. Our core services, which we provide to more than , people, cover more than 2, square miles across Devon, while some of our specialist services cover the whole of the peninsula, extending our reach as far as Cornwall and the Isles of Scilly.

We deliver a wide range of emergency, specialist and general medical services through North Devon District Hospital and the Royal Devon and Exeter Hospital (Wonford). Alongside our two acute hospitals, we provide integrated health and social care services across a variety of settings, including community inpatient hospitals, outpatient clinics, and within people’s own homes. We also offer primary care services, a range of specialist community services, and Sexual Assault Referral Centres (SARC).

Our state-of-the-art equipment, leading technologies and strong links to local universities put us at the forefront of research and innovations, enabling us to provide world-class care to our local communities.

Our values are at the heart of everything we do.

It has never been a more exciting time to join the Royal Devon, as you will help to shape our services as we continue along our integration journey.

Looking after you is important to us.

We strive to help our staff create a healthy work-life balance through flexible working schemes and our family friendly policies.

If you are starting out in the NHS, you’ll start with days paid annual leave (plus bank holidays), rising to days plus bank holidays.

You will benefit from access to our own comprehensive occupational health services, including counselling, onsite wellbeing activities and groups.

We will work together to maintain a culture that develops and supports you and your team.

This might include funding for a care certificate, a degree or leadership qualifications. Or it might include days off to study, engage in CPD or rotational placements to help you hone your skills. Wherever you are heading in the NHS, we will help you get there.

Salary is not the only financial benefit.

You will have access to an extensive range of staff discounts on shopping, fitness and leisure options and you can spread the cost of technology and home appliance purchases from major retailers. You will also have access to other benefits including:

• National discount services such as the Blue Light Card and Health Service Discounts.
• Salary sacrifice options including our OFSTED rated outstanding nursery onsite at Exeter.
• Car lease schemes.
• The NHS Pension scheme (one of the most generous and comprehensive in the UK).
• Cycle to work scheme.

These are just a few of the benefits available – if the role is something you are interested in, we would love to hear from you.