Job summary
This new post is a unique and exciting opportunity for a pharmacy professional seeking a challenging and rewarding role to join the South West Regional Quality Assurance (RQA) team which is hosted by NBT. You will work collaboratively as part of our team to enhance quality assurance and quality management across the SW region, as well as helping to deliver NHS England Specialist Pharmacy Service quality assurance related activities.
We are seeking a motivated individual who has the ability to work independently and as part of a team. You will have experience of providing quality assurance and quality management services to licensed and/or unlicensed units combined with in-depth knowledge of the quality factors affecting medicines and the potential impact on patient safety.
You will use your subject matter expertise in pharmaceutical quality assurance in a varied and interesting role which will include auditing, development of collaborative initiatives to improve GxP and quality management across Trusts, support with quality aspects of regional medicines procurement, and promote regional training and sharing of best practice.
While the role is hosted by NBT, there is an opportunity for home-based working. The role involves a considerable amount of travel, principally within the SW region but also to other areas of the UK. The post is full-time, however applications for flexible working, job share and part-time may be considered where they meet the needs of the service.
Main duties of the job
To support Trusts in the SW region through the following:
1. To provide expert quality assurance advice and support to NHS organisations carrying out sterile & non-sterile traditional batch manufacture, aseptic preparation, radiopharmacy, extemporaneous preparation, repackaging & over labelling, wholesaler dealing, clinical trials, medical gases and quality control laboratory services.
2. Independent audit of the licensed and unlicensed GxP activities above against relevant standards to supplement Trusts' self-inspection programmes.
3. Provision of quality assurance support to regional purchasing consortiums tender processes focussing on quality assurance aspects of tender specifications and product evaluation stability, manufacturing processes.
4. To work in collaboration with the SW Regional Pharmacy Procurement team on areas of joint quality assurance and procurement related matters in line with commissioner saving plans.
5. To work in collaboration with Pharmacy Workforce Development South to co-ordinate, develop and deliver specialist training in relation to GxP activities.
6. To coordinate and promote common ways of working across the region with shared practices and development of best practice guidance in relation to professional standards, regulations, and common audit deficiencies.
7. To facilitate and support Aseptic Units with local implementation of shared practice, driving efficiencies in local management of pharmaceutical quality systems and building regional resilience.
About us
North Bristol NHS Trust employs over 12,000 staff providing healthcare to the residents of Bristol, South Gloucestershire and North Somerset from our award-winning hospital building at Southmead. We are the regional Major Trauma Centre, and an internationally recognised centre of excellence in a range of services and major specialities. Our vision is that by enabling our teams to be the best that they can be, we will provide exceptional healthcare, personally delivered.
We commit to treating each patient as an individual with respect and dignity, aiming to deliver excellent clinical outcomes and a first-class experience for everyone who uses our services.
North Bristol NHS Trust values all people as individuals. We aim to be an anti-discriminatory organisation and are committed to building a team that represents a variety of backgrounds, perspectives, and skills. We welcome applicants from all underrepresented groups.
Bristol is consistently voted the best place to live in the UK, with vibrant local music, arts and gastronomic scenes, a wide range of modern and state of the art shopping, recreation and leisure facilities, a wealth of great local family days out, fantastic transport links for local, national and internal holidays, and it has a rich history. If you prefer country, village or smaller town living, NBT is also easily commutable from a range of attractive locations in North Somerset, South Gloucestershire and South Wales ( Portishead, Chepstow).
Job description
Job responsibilities
Please see full details of this post and the essential experience in the attached job description and person specification.
To learn more about Pharmacy at NBT, click here to watch our video.
Person Specification
Qualifications
Essential
8. Pharmacist or Pharmacy Technician (registered with the General Pharmaceutical Council) or Pharmaceutical or Healthcare Scientist (registered or eligible to register with a relevant professional body eg Royal Society of Chemistry).
9. MPharm or Bsc in Pharmacy plus 1 years pre-registration, or a relevant science. Or (for Pharmacy Technicians) BTEC in pharmaceutical services, or Level 3 NVQ diploma in Pharmacy Services and the Level 3 Diploma in Pharmaceutical Science.
10. Post-graduate diploma or equivalent specialist qualification in relevant aspect of pharmaceutical sciences such as PTQA, or equivalent extensive experience and specialist knowledge in quality assurance.
Work Experience
Essential
11. In depth specialist knowledge of pharmaceutical quality systems, GMP, GDP, MHRA standards, the Medicines Act and other relevant legislation and guidance.
12. Experience of providing Quality Assurance and Quality Management services to MHRA licensed units and/or those operating under a Section 10 exemption.
13. Experience and understanding of NHS contracting and procurement of medicines.
14. In depth specialist knowledge and experience of the quality factors affecting medicines and their impact on safety and efficacy for patients.
15. Experience and knowledge of current pharmaceutical analysis (Chemical, Physical and Microbiological) of both an innovative and routine nature.
16. Experience of developing and delivering education and training.
Desirable
17. Experience of auditing hospital pharmacy technical services, manufacturers and/or suppliers to GxP standards, including ensuring that action plans are agreed and implemented.
18. Planning, organisation and service management experience of pharmacy Quality Assurance or technical services in the NHS or commercial sector.
Knowledge/Skills/Abilities
Essential
19. Excellent interpersonal skills.
20. Visionary and ability to motivate others.
21. Ability to manage own time and workload autonomously with good organisational skills.
22. Ability to act independently on own initiative and work as a part of a team and across teams.
23. Ability to plan and organise research, training and audit activities.
24. Ability to concentrate for frequent prolonged periods during audits and writing audit reports. Often interrupted by urgent requests and with an unpredictable work pattern.
25. Ability to work under pressure, in a changing strategic environment, to tight deadlines, and with competing agendas.
26. Ability to motivate and influence the work of others to achieve change within hospital pharmacy departments within the SW Region in order to meet national guidelines and regional advice.
27. Ability to communicate, influence and negotiate effectively at regional and local level.
28. Professional and personal integrity including a recognised equitable approach.
29. Proven facilitative leadership skills including ability to chair meetings at regional level.
30. Effective presentation skills including the ability to deliver presentations to specialist and non-specialist groups.
31. Problem identification, prioritisation and solving skills.
32. Ability to resolve highly complex problems relating to product quality and patient safety and to communicate highly complex information effectively.
33. Ability to negotiate and influence senior professionals regarding product quality and patient safety risks where advice may be challenged.
34. Ability to analyse and interpret highly complex data, results and statistics and to present results coherently.
35. Ability to apply quality assurance expertise to support regional procurement activities, including review of tender specifications for relevant contract lines and performing product quality assessments.
36. Computer literate.
Desirable
37. Proven experience of working at a strategic level with senior clinicians, managers and across the wider health community.
Personal Qualities/Special Circumstances
Essential
38. Full UK driving licence/ability to travel to sites across the SW region as required.