Job overview
Barts Health Pharmacy Technical Services (PTS) is part of Barts Health NHS Trust and has seen significant changes over the last few years, and the evolving team of pharmacists, technicians, scientists and assistants in the Pharmacy Quality Department continue to ensure and maintain high standards of Good Manufacturing Practices (GMP) across the four licensed ‘Specials’ units that are managed over three hospital sites. An exciting opportunity has arisen to recruit a Deputy Head of Quality to support the Head of Quality in developing, delivering and maintaining the high standards required to ensure patient medication is produced to the highest quality.
Provisional interview date:11th December 2024
Main duties of the job
The post holder is required to assist in maintaining the integrated quality systems across the licensed units. They will gain in-depth knowledge and understanding of the management, regulatory and control of the four sites. They will be involved in continuous improvement project work associated with service development to maintain the reliability and capabilities of the quality unit.
Candidates should have a qualification in Pharmacy or a relevant science degree with membership of the relevant professional body. They will have experience of working within a GMP facility, with thorough understanding of current Good Manufacturing Practices and Good controlled Laboratory Practices (GcLP). Working in a hospital setting, linked to an MHRA Licensed Pharmacy Manufacturing unit as well as managerial experience is also desirable. The applicant must be efficient, organised, proactive and able to forge relationships with a wide range of staff within and beyond pharmacy quality. Working within the team and autonomously across multiple sites, will be able to deal with queries and make risk-based decisions to maintain compliance with the licence requirements as well as safe supply of medicines to the patients. The post holder will also be required to travel between multiple sites.
Working for our organisation
Barts Health is one of the largest NHS trusts in the country, and one of Britain’s leading healthcare providers.
The Barts Health group of NHS hospitals is entering an exciting new era on our improvement journey to becoming an outstanding organisation with a world-class clinical reputation. Having lifted ourselves out of special measures, we now have the impetus and breathing space to chart a fresh course in which we are continually striving to improve all our services for patients.
Our vision is to be a high-performing group of NHS hospitals, renowned for excellence and innovation, and providing safe and compassionate care to our patients in east London and beyond. That means being a provider of excellent patient safety, known for delivering consistently high standards of harm-free care and always caring for patients in the right place at the right time. It also means being an outstanding place to work, in which our WeCare values and behaviours are visible to all and guide us in how we work together.
We strive to live by our WeCare values and are committed to promoting inclusion, where every staff member has a sense of belonging. We value our differences and fully advocate, cultivate and support an inclusive working environment.
We particularly welcome applications from Black, Asian and minority ethnic candidates as they are underrepresented within Barts Health at this band.
Detailed job description and main responsibilities
We are dedicated to being an outstanding place to work and will work with you to get the best experience. We know flexible working is not a one size fits all and will mean something different to everyone. We are inclusive, so if you are interested in flexible working, please speak to the recruiting manager.
The full job description provides an overview of the key tasks and responsibilities of the role, and the person specification outlines the qualifications, skills, experience, and knowledge required. For both documents, please view the attachment/s below.
For further information or to arrange an informal visit, please contact: Clarissa Coker (Head of Quality) on 0203 246 0267 or e-mail .
Person specification
Experience
Essential criteria
1. Demonstrate knowledge of cGMP/GLP/Quality systems
2. Demonstrates experience in the application of Human Resource Policies and Procedures
3. Proven experience of good performance in previous posts and managing teams in GMP environments
4. Demonstrates ability to identify facility and equipment problems, troubleshoot, prioritise, and resolve them. Advise on quality issues with manufacturing teams to maintain GMP and patient safety
5. Demonstrates ability to manage QMS including deviations, CAPAs Change Controls and develop and review action plans
6. Demonstrates expert experience & ability to produce production & quality related documentation
7. Demonstrates expert experience in performing and receiving audits from external agencies
8. Demonstrates competent experience and ability to successfully undertake a range of technical projects
Desirable criteria
9. Experience of working in a QA/QC laboratory
10. Experience of medical piped gases
11. Experience of working with radiopharmaceuticals
12. Demonstrated knowledge of pharmaceutical microbiology.
Skills
Essential criteria
13. Demonstrated ability to identify problems, analyse root cause and propose solutions for complex problems
14. Able to manage deviations and incidents and develop and review action plans to resolve them
15. Able to develop and review options appraisal’s and identify the most appropriate option
16. Effective leadership skills
17. Advanced IT skills including email, word processing, spreadsheets, databases, accurate data entry and use of specialist computer programmes
18. Methodical with good attention to detail
Desirable criteria
19. Able to write business cases
Knowledge
Essential criteria
20. Demonstrated expert technical knowledge of GcLP and cGMP, and a proven ability to apply this knowledge to maintain, develop and validate quality systems
21. Knowledge of the eight core principles of ISO9001 Quality Management
22. Knowledge of Aseptic Practices
23. Working knowledge of gap analysis and action plans
24. Knowledge of all regulatory Standards: UK and EU legislation regarding cGMP, GcLP, cGCP
25. Knowledge of COSHH and health and safety at work
26. Knowledge of conducting Internal and external self-inspection and Audits
27. Expert knowledge of validation
28. Expert knowledge of project management
Desirable criteria
29. Knowledge of development and validation of various analytical techniques and radiopharmacy
30. Knowledge of development and validation of various analytical techniques and radiopharmacy
31. Experience in design, development and undertaking stability studies.
Qualifications
Essential criteria
32. Master’s degree in pharmacy or relevant Science Degree
33. Full membership of a relevant professional body e.g. General Pharmaceutical Council (GPhC), or Royal Society of Chemistry (RSC) or Biology (RBS)
Desirable criteria
34. Specialist postgraduate Diploma/MSc in technical Services (e.g. National Course in Pharmaceutical Technology and Quality Assurance) or equivalent work based technical experience and underpinning knowledge
35. Experience of Hospital environments
Other
Essential criteria
36. Excellent verbal and written communication and presentation skills suitable for a range of audiences, including chairing meetings
37. Experience in giving presentations to diverse audiences.
38. Awareness of the need of confidentiality
Skills
Essential criteria
39. Good team working skills
40. Organisation and prioritisation of workload to meet deadlines
Desirable criteria
41. Able to communicate effectively with all health care professionals, colleagues, contractors, service providers
42. Excellent verbal and written communication skills
Other
Essential criteria
43. Required to wear specialised clean room clothing and appropriate Personal Protective Equipment (PPE)