Job summary
We have a fabulous opportunity for a Specialist Pharmacist (Band 7) - Technical Services to join our aseptic team at Royal Blackburn Hospital.
This role will focus on ensuring the effective and efficient quality assurance of unlicensed aseptic products and to provide support for the specialised chemotherapy clinical service.
The Technical service operates under the section 10 exemption of the Medicine Act 1968 (as referenced in The Human Medicines Regulations 2012) and comply with the standards of the Quality Assurance of Aseptic Preparation services QAAPs.
We are seeking a motivated individual who demonstrates commitment, accountability and is a positive role model for our Aseptic Technical Team and Chemotherapy Clinical Team.
We need a team player with technical and clinical skills to help develop a complex part of our pharmacy service.
We want your enthusiasm and ideas in to providing a first-class pharmacy service in our busy Cancer Unit, tertiary Neonatal and Hepatobiliary (HBP) service.
The service is undergoing developments and you will help with the project and look at expanding the service towards a Specials Manufacturing Licence.
For further information or to arrange an informal visit, contact Alessandro Latella (Principal Pharmacist- Technical Services).
We have 2 positions available
Main duties of the job
Technical Services deliver a central intravenous additive service (CIVAS) providing an adult and neonatal parenteral intravenous service (TPN), complex no cancer monoclonal antibodies (MABs), chemotherapy, immunotherapy, complex clinical trials, antibiotics, and continuous infusions, for clinical areas across Blackburn and Burnley site.
You will have excellent capabilities to work as a team member, essential for creating, improving, and sustaining the safety, quality, and efficiency of our service and the Quality Management System to ensure we maintain compliance with Good Manufacturing Practice, regulatory and legislative requirements.
Integral to the role will be:
1. Acting as "Authorising Pharmacist" under section 10 exemption
2. Adherence with the overarching Pharmaceutical Quality Management System (PQS) for Technical Services
3. Provision of leadership with regards to all operational quality aspects
4. Provision of a Specialist Oncology Service.
5. Supporting the Principal Pharmacist in building and maintaining a robust Quality Management System (QMS).
About us
This is an exciting time for Aseptic Services with NHSE's future plans for transformation and investment. This post holder will be instrumental in helping to inform and shape aseptic services for the Trust and across the ICS in the advent of future hub and spoke models, ensuring that quality assurance and patient safety will be at the heart of everything to we do.
We value the personal skills, experiences, and qualities that individuals bring to our department and the Trust; creating an inclusive working environment to attract talented people who feel motivated, involved, and able to influence the future direction of our services. The well being of staff is important to us; we have a dedicated Health and Well being team who provide support on a range of topics, run fitness classes, and organise mindfulness sessions. As an employer we have earned a reputation for focusing on the development of our staff and for being an organisation people are proud to work for.
Job description
Job responsibilities
The post holder will:
6. Assist the Lead Oncology Pharmacist, Lead Aseptic Pharmacist and Lead Clinical Trials Pharmacist on all aspects of the service, on matters relating to aseptic dispensing, the aseptic preparation of parenteral drugs, investigational medicinal products (IMPs) and the regulatory aspects of pharmacist supervision in unlicensed and licensed premises.
7. Work with the Lead Aseptic Pharmacist and Principal Pharmacist for technical services to maintain and improve the pharmaceutical quality system and participate actively at quality management system meetings.
8. Work closely with the wider aseptic team to ensure the smooth running of the aseptic units.
9. Maintain a high quality, cost effective and efficient patient-centred pharmacy service in the provision of aseptic services.
10. Assist the senior pharmacy technical services team to ensure that clinical trials are set up and conducted in accordance with Good Clinical Practice (GCP), and aseptic products are prepared in accordance with Good Manufacturing Practice (GMP) and all relevant medicines regulations and ethical requirements, to ensure the product is fit for its intended use.
11. Contribute and support the Principal Pharmacist for technical services in maintaining the document control system, reviewing as per schedule any relevant procedures and worksheets.
12. Assess the stability of new and existing products, investigate deviations, and determine root causes, and contribute to the development of corrective and preventative actions.
13. Complete internal audit and quarterly unit inspections, identify gaps with standards and agree action plans with the Senior Aseptic team.
14. Assist with the Planned Preventative Maintenance and Validations programme for the Technical Services Unit.
15. Contribute to the development of other staff and provide professional leadership and supervision to the haemato-oncology/aseptic service.
16. Be responsible for the day-to-day delivery of haemato-oncology clinical pharmacy service, under the overall direction of the Lead Oncology Pharmacist
17. Provide a consistently high level of pharmaceutical service in line with corporate objectives and government initiatives.
18. Identify risk management issues and assist in developing safe systems of practice with the aseptic/chemotherapy service.
19. Audit, monitor and develop medicines optimisation in line with Pharmacy Directorate strategy and objectives.
Person Specification
Qualification
Essential
20. MPharm Degree (4 years) or equivalent
21. Member GPhC.
Desirable
22. Pharmaceutical Technology and Quality Assurance (PTQA) Diploma.
23. Postgraduate clinical diploma.
24. Non-Medical Prescribing.
Experience
Essential
25. Experience in Aseptic service and relevant clinical experience
26. Experience in writing and developing SOP
27. Advance practice in one or more area
Desirable
28. Experience in managing change
29. Experience in undertaking internal audits
30. Experience working in clinical trials
Knowledge and Skills
Essential
31. Understanding of local and national NHS and Pharmaceutical Policy
32. Expert knowledge of GCP/GMP/GDP
33. Knowledge of clean room designs and regulations
34. Understanding of risk management and principles of clinical governance
35. Able to communicate highly complex information to senior staff both within and outside pharmacy and patients
Personal Attributes
Essential
36. Able to prioritise workload and work under pressure
37. Flexible working