Job summary
Newcastle upon Tyne Hospitals NHS Foundation Trust hosts the Specialist Pharmacy Service's Quality Assurance services for the North East and Yorkshire. In this exciting post, there will be opportunities for both regional and national work. The successful candidate will train as an Assurance Auditor for Aseptic Preparation units, as well as being given the opportunity to work with colleagues to develop expert content for national guidance which appears on the widely used SPS website.
This post represents a fantastic opportunity for learning and development and is suitable for candidates wishing to specialize in this area of pharmacy technical services.
- Interview Date Wednesday, 25 September 2024
- 7 Hours 30 Minutes/Week
- You will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy
Main duties of the job
The postholder will visit pharmacy aseptic units as an auditor for the Specialist Pharmacy Service (full training provided). Using your expert technical knowledge of good manufacturing practice and experience of aseptic services, you will assess the performance of aseptic preparation unit against nationally agreed standards. You will feedback your findings to senior pharmacy leaders and will document your finding within iQAAPs, the NHS's electronic system - information from which provides national oversight of this important service to provide assurance re the quality of medicines that NHS patients receive.
The Specialist Pharmacy Service has a QA team in every NHSE region. You will work collaboratively on the production of guidance in webpage format to facilitate consistent advice and implementation in sites across the country.
As a member of the SPS regional team for North East and Yorkshire you will assist with a wide range of enquiry answering.
The successful candidate will have excellent written and verbal communication skills and be passionate about furthering their career in technical services.
About us
Newcastle Hospitals NHS Foundation Trust is one of the busiest, largest and most successful teaching NHS foundation trusts in the country, with around 16,000 staff and an annual income of £1 billion.
We have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally.
We're also proud to be the second largest provider of specialised services in the country. This means we support people with a range of rare and complex medical, surgical and neurological conditions, cancers and genetic orders.
Our staff oversee around 2 million patients 'contacts' each year, delivering high standards of healthcare.
Please see attached information on what Staff Benefits we have to offer at our Trust.
We are committed to promoting equality and diversity and recognise the benefit in providing an inclusive environment. We value and respect the diversity of our employees and aim to recruit a workforce which reflects the communities we serve, and is equipped to deliver the best service to our patients. We welcome all applications irrespective of people's race, disability, gender, sexual orientation, religion or belief, age, gender identity, marriage and civil partnership, pregnancy and maternity and in particular those from under- represented groups.
Job description
Job responsibilities
To deliver a range of specialist Quality Assurance duties as part of the North East Pharmaceutical Quality Assurance team relating to:
- Medicine Preparation Audit & Support
- Quality Risk Management of the Medicines Supply chain
- Safe and secure handling & distribution of medicines
- Workforce development
- Quality system management
As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.
Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate. The method of payment is a salary deduction from your first months pay.
Job description
Job responsibilities
To deliver a range of specialist Quality Assurance duties as part of the North East Pharmaceutical Quality Assurance team relating to:
- Medicine Preparation Audit & Support
- Quality Risk Management of the Medicines Supply chain
- Safe and secure handling & distribution of medicines
- Workforce development
- Quality system management
As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you.
Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate. The method of payment is a salary deduction from your first months pay.
Person Specification
Qualifications
Essential
- Masters degree in Pharmaceutical Technology & Quality Assurance Or Masters Degree in Pharmacy Or equivalent experience to Masters degree level e.g. Masters degree in pharmaceutical sciences, chemistry, or Medicines Management and Pharmacy services
- Basic qualification in pharmaceutical sciences (BTEC) or an equivalent scientific qualification to same level.
Desirable
- Further qualification in risk management
- Member of a recognised professional body e.g. Royal pharmaceutical society
Experience
Essential
- Extensive post qualification experience including: Extensive experience of Good Manufacturing Practice relating to pharmaceutical manufacturing and preparation
- Significant experience of risk management and quality management systems and their application.
- Experience of auditing and self inspection to meet pharmaceutical regulatory requirements
- Experience in the planning and delivery of training (large and small groups).
- Experience of multi-disciplinary working and to have evidence to demonstrate successful management of significant changes in complex environments
- Experience and evidence of successful development and implementation of policies and procedures to satisfy regulatory requirements
Desirable
- Experience of quality assessment of pharmaceuticals
- Experience of supporting the outsourcing of medicines and services by the NHS
Knowledge
Essential
- Specialist knowledge of the regulatory and NHS standards and guidance relating to medicines manufacture and preparation.
- Specialist knowledge of the regulatory and NHS standards and guidance relating to the safe storage and supply of medicines
- Specialist knowledge of the standards and guidance relating to homecare medicines services.
- Specialist knowledge of the principles of quality risk management as applicable to medicines manufacture and preparation
- Specialist knowledge of clean-room design, technology and operation for pharmaceutical processing
- Understanding of pharmaceutical quality control testing methods and their application to medicines manufacture and preparation
Desirable
- Understanding of the regulatory and NHS standards and guidance relating to medicines procurement and supply
- Understanding of health and safety legislation as applicable to medicines manufacture and preparation.
Skills
Essential
- Excellent communication skills (written, listening and oral) to ensure effective communication with individuals and groups, including those where the information is complex or there are barriers to understanding
- Excellent presentation and facilitation skills within both small groups and large workshops
- Diplomatic, consultative and able to build consensus to successfully gain agreement and commitment with peers and customers. Able to cope with conflict and handle difficult situations with a calm disposition
- Ability to coach and mentor others
- Excellent time management and organisational skills, with an ability to plan and schedule a broad range of complex activities.
- Excellent investigational and analytical skills with an ability to provide advice in highly complex situations.
- Able to concentrate for prolonged periods while dealing with interruptions
- Demonstrates tact, empathy and diplomacy when communicating confidential, sensitive or contentious information
- Good IT skills - ability to accurately produce documentation and presentations using Microsoft packages
- Willing to travel to other hospital sites
- Able to fulfil Occupational Health requirements for the post (with reasonable adjustments if necessary)
Person Specification
Qualifications
Essential
- Masters degree in Pharmaceutical Technology & Quality Assurance Or Masters Degree in Pharmacy Or equivalent experience to Masters degree level e.g. Masters degree in pharmaceutical sciences, chemistry, or Medicines Management and Pharmacy services
- Basic qualification in pharmaceutical sciences (BTEC) or an equivalent scientific qualification to same level.
Desirable
- Further qualification in risk management
- Member of a recognised professional body e.g. Royal pharmaceutical society
Experience
Essential
- Extensive post qualification experience including: Extensive experience of Good Manufacturing Practice relating to pharmaceutical manufacturing and preparation
- Significant experience of risk management and quality management systems and their application.
- Experience of auditing and self inspection to meet pharmaceutical regulatory requirements
- Experience in the planning and delivery of training (large and small groups).
- Experience of multi-disciplinary working and to have evidence to demonstrate successful management of significant changes in complex environments
- Experience and evidence of successful development and implementation of policies and procedures to satisfy regulatory requirements
Desirable
- Experience of quality assessment of pharmaceuticals
- Experience of supporting the outsourcing of medicines and services by the NHS
Knowledge
Essential
- Specialist knowledge of the regulatory and NHS standards and guidance relating to medicines manufacture and preparation.
- Specialist knowledge of the regulatory and NHS standards and guidance relating to the safe storage and supply of medicines
- Specialist knowledge of the standards and guidance relating to homecare medicines services.
- Specialist knowledge of the principles of quality risk management as applicable to medicines manufacture and preparation
- Specialist knowledge of clean-room design, technology and operation for pharmaceutical processing
- Understanding of pharmaceutical quality control testing methods and their application to medicines manufacture and preparation
Desirable
- Understanding of the regulatory and NHS standards and guidance relating to medicines procurement and supply
- Understanding of health and safety legislation as applicable to medicines manufacture and preparation.
Skills
Essential
- Excellent communication skills (written, listening and oral) to ensure effective communication with individuals and groups, including those where the information is complex or there are barriers to understanding
- Excellent presentation and facilitation skills within both small groups and large workshops
- Diplomatic, consultative and able to build consensus to successfully gain agreement and commitment with peers and customers. Able to cope with conflict and handle difficult situations with a calm disposition
- Ability to coach and mentor others
- Excellent time management and organisational skills, with an ability to plan and schedule a broad range of complex activities.
- Excellent investigational and analytical skills with an ability to provide advice in highly complex situations.
- Able to concentrate for prolonged periods while dealing with interruptions
- Demonstrates tact, empathy and diplomacy when communicating confidential, sensitive or contentious information
- Good IT skills - ability to accurately produce documentation and presentations using Microsoft packages
- Willing to travel to other hospital sites
- Able to fulfil Occupational Health requirements for the post (with reasonable adjustments if necessary)
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Additional information
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
