Job overview
PLEASE NOTE THAT WE WILL ONLY ACCEPT APPLICATIONS FROM STAFF CURRENTLY EMPLOYED BY SWANSEA BAY UNIVERSITY HEALTH BOARD
We have an exciting opportunity for a highly motivated Quality Assurance Specialist to join the Pharmacy Quality team. Working closely with the Head of Quality, you will play a key role in maintaining and developing the Pharmaceutical Quality System, supporting compliance with regulatory and licensing requirements across Pharmacy Technical Services.
This role involves leading and supporting environmental monitoring activities, providing specialist analytical services, and ensuring that operations meet GMP, UKAS accreditation (ISO 17025 / ISO 9001), and national/international standards.
Main duties of the job
1. PQS Support & Development: Assist the Head of Quality in maintaining and improving the Pharmaceutical Quality System in line with regulatory, legislative, and licence requirements.
2. Environmental Monitoring Lead: Provide leadership and support to environmental testing activities across Pharmacy cleanroom and aseptic services.
3. Internal Auditing: Undertake internal audits of PQS processes including testing programmes, validation work, deviation handling, and non-conformances across both physical and microbiological laboratories.
4. Analytical Service Provision: Deliver a GMP-compliant and UKAS-accredited environmental monitoring service to NHS internal stakeholders and commercial clients. This includes microbiological and air particulate analysis for aseptic suites and cleanroom facilities across Wales (and occasionally beyond).
5. Product Release: Act as a releasing officer for products manufactured under the Manufacturer’s “Specials” (MS) Licence, ensuring documentation and product quality meet regulatory standards.
6. Health & Safety Leadership: Lead on Health & Safety within NWSSP Pharmacy, including COSHH management, risk assessment systems and advising staff on safe working practices.
7. Training & Specialist Advice: Provide training and expert guidance on PQS processes, environmental monitoring, and H&S compliance to staff across the department.
Working for our organisation
We believe staff are our best asset and we want you to be happy and confident about starting your career here in Swansea Bay University Health Board.
As one of the biggest healthcare groups in the UK we can offer a wealth of professional training and development opportunities in an innovative, forward-thinking organisation.
You might be a nurse or doctor, maybe you specialise in a health science/therapy or can offer skills in one of our support services - we have a job for you.
There are also apprenticeships, work placements and volunteering roles available.
We are an inclusive employer and welcome applications from everyone whatever their sex; religion or belief; race; age; sexual orientation; gender identity or, whether they are pregnant or have recently been on maternity leave, married or are in a civil partnership; or, whether they are disabled.
Our values - Caring For Each Other, Working Together and Always Improving, show that our commitment to equality is at the heart of everything we do.
If you want excellent career and training opportunities while living on the doorstep of some of Europe's most spectacular scenery, with all the benefits of a thriving and cosmopolitan city - look no further.
Detailed job description and main responsibilities
A comprehensive and detailed overview of the primary duties and responsibilities associated with this position is available in the job description.
Person specification
Qualifications
Essential criteria
8. MSC in Pharmacy, Pharmaceutical Technology and Quality Assurance (PTQA), Clinical Pharmaceutical Science or any other relevant Science or the equivalent appropriate experience.
9. Have significant theoretical knowledge of GMP guidance, providing health and safety advice, and of the principles and theory underlying environmental monitoring (such as clean room testing).
10. Knowledge of the role and responsibilities of a Quality department in an ISO 17025 laboratory or ISO 13485 and 9001.
11. Knowledge of microbiological principles and aseptic techniques. Requires knowledge of current national and international standards relevant to clean room monitoring and testing of medical devices.
12. Knowledge of laboratory instrumentation, analytical techniques and microbiology.
Desirable criteria
13. Higher education qualification relevant to post.
14. Knowledge and experience of other laboratory quality management systems.
15. Knowledge of NHS working procedures.
Experience
Essential criteria
16. Have significant practical experience from working in a GMP testing laboratory, providing health and safety advice.
17. Experience in microbiology and aseptic technique
Desirable criteria
18. Experience of participation with gaining UKAS accreditation. UKAS ISO 17025 and 9001 Experience of Maldi Tof mass spectrometry
Aptitude
Essential criteria
19. Good Information technology skills
20. Good mathematical and basic statistical skills. Competent in the use and operation of environmental monitoring and gas testing equipment.
21. Ability to prioritise workload
22. Deliver excellent customer service to our internal and external customers, helping us to maintain the customer service excellence standard.
Swansea Bay University Health Board is committed to supporting its staff and processes to fully embrace the need for bilingualism thereby enhancing service users experience. In our commitment to increase the number of staff able to communicate in Welsh with patients and professionals, we would particularly welcome applications from Welsh speakers.
Equality remains at the centre of the Health Boards policy-making, service delivery and employment practices. We value the diversity of our staff and welcome applications from people from protected groups under the Equality Act 2010, this specifically includes age, gender, sexual orientation, gender identity/reassignment, race, religion, disability, pregnancy and maternity and marriage and civil partnership.
Employer certification / accreditation badges
Applicant requirements
You must have appropriate UK professional registration.
This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.
Welsh language skills are desirable