Job summary
Due to service expansion an exciting opportunity has arisen for a highly motivated, qualified Pharmacy Technician to join the Pharmacy Directorate and make a significant contribution to improving patient outcomes.
The successful candidate will make a significant contribution in delivering innovative, world-leading research by providing essential oversight and aseptic preparation of advanced therapy products, including cell and gene therapies, for clinical trials and NHS services.
Newcastle Advanced Therapies is an integral part of the Pharmacy Directorate at the Newcastle upon Tyne Hospitals NHS Foundation Trust. We work in partnership with Newcastle University to provide a comprehensive service in processing, storage, development, and manufacture of advanced therapy products. Newcastle Advanced Therapies operate a JACIE accredited, MHRA and HTA licensed GMP cleanroom complex across two sites at the Royal Victoria Infirmary and the International Centre for Life. We have a well-established Haematology Transplant service and a strong record of accomplishment in delivering ATIMP clinical trials.
The service provides clinical transplantation to over 300 patients per annum and over 500 products pass through the service. The post holder will participate as part of a team in delivering a high-quality service across all sites.
- Interview Date Monday, 26 February 2024
- 37 Hours 30 Minutes/Week
Main duties of the job
- Close working with a wide network of designated individuals including scientists, clinicians and pharmacists.
- Participation in an out of hours on call service.
- Operation, maintenance and monitoring of clean rooms in accordance with HTA/MHRA/JACIE/QAAPs requirements.
- Participation in service and product improvement through continual education, audits, and training.
- Taking an active role in policy, product and service development.
- Attending clinical areas (wards, theatres) on any of the trust sites to assist clinical staff in the delivery and administration of Cell, Gene and Tissue products.
- Overseeing technical staff in the preparation of specimens for analysis, including the reception, processing, preservation, labelling, storage, distribution and disposal of products.
- Recording and correcting minor non-compliances (deviations) and immediately reporting any major deviations to a senior member of staff as per local policy.
- Working in compliance with local health and safety rules to ensure a safe working environment. To adhere to department and Trust Health and Safety policies.
- Awareness of the requirements from regulatory bodies applicable to the role (HTA, JACIE, MHRA, QAAPs) and perform all duties in accordance with the local Quality Assurance System.
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
- The post holder is responsible for the aseptic preparation, in accordance with GCP and GMP, of cell and gene therapy products, for use as licensed medicines or clinical trials, in the Cell, Gene and Tissue Laboratory including the organisational and service management requirements underpinning the processes.
- Support the releasing process which involves assessment and release of all advanced therapy medicinal products prepared by Newcastle Advanced Therapies under Section 10 and Regulation 37 exemptions.
- Providing pharmaceutical quality assurance (QA) support to Newcastle Advanced Therapies.
- Support the quality assurance processes for advanced therapy medicinal products prepared for use in the Trust.
- To have specific responsibilities as a pharmacy technician in Newcastle Advanced Therapies as delegated by the accountable pharmacist and/or Production Manager.
- Managing complaints regarding defective licensed medicines.
- Managing minor defects reporting within the Trust and collation of data for national reporting.
- Preparation and approval of documentation, e.g., standard operating procedures, batch manufacturing records, medicines specifications etc.
- Contribute to the education and training of staff in relation to QA activities.
- Carry out other duties, as required, to support a busy clinical service in the quality assurance and preparation of advanced therapy products across a range of regulatory standards including QAAPs, HTA, JACIE and the MHRA.
The post holder will contribute to the provision and development of laboratory services, through innovative thinking and improvement mapping.
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.
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.
Job description
Job responsibilities
- The post holder is responsible for the aseptic preparation, in accordance with GCP and GMP, of cell and gene therapy products, for use as licensed medicines or clinical trials, in the Cell, Gene and Tissue Laboratory including the organisational and service management requirements underpinning the processes.
- Support the releasing process which involves assessment and release of all advanced therapy medicinal products prepared by Newcastle Advanced Therapies under Section 10 and Regulation 37 exemptions.
- Providing pharmaceutical quality assurance (QA) support to Newcastle Advanced Therapies.
- Support the quality assurance processes for advanced therapy medicinal products prepared for use in the Trust.
- To have specific responsibilities as a pharmacy technician in Newcastle Advanced Therapies as delegated by the accountable pharmacist and/or Production Manager.
- Managing complaints regarding defective licensed medicines.
- Managing minor defects reporting within the Trust and collation of data for national reporting.
- Preparation and approval of documentation, e.g., standard operating procedures, batch manufacturing records, medicines specifications etc.
- Contribute to the education and training of staff in relation to QA activities.
- Carry out other duties, as required, to support a busy clinical service in the quality assurance and preparation of advanced therapy products across a range of regulatory standards including QAAPs, HTA, JACIE and the MHRA.
The post holder will contribute to the provision and development of laboratory services, through innovative thinking and improvement mapping.
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.
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.
Person Specification
Qualifications & Education
Essential
- Registrant of the General Pharmaceutical Council (GPhC)
- Degree (in a scientific subject e.g., Chemistry or Pharmacy) or equivalent qualification / relevant experience
Knowledge & Experience
Essential
- Up to date knowledge and understanding of Good. Manufacturing Practice and its application
- Knowledge of Quality Assurance of Aseptic Preparation Service (QAAPS) standards including Section 10 and Regulation 37 exemptions
- Evidence of professional CPD
- Post qualification experience within the pharmacy sector
Desirable
- A wide variety of hospital pharmacy experience
- Experience of working in a GMP environment
- Knowledge of MHRA Guidance in relation to unlicensed and licensed medicines
- Knowledge of HTA regulations for the receipt, storage and distribution of cells and tissues
- Working knowledge of the preparation of advanced therapy medicinal products (ATMPs)
- Experience of managing operational activity within a pharmacy setting
- Evidence of further training in quality assurance
Skills & Abilities
Essential
- Able to work carefully and methodically
- Good keyboard and general IT skills
- Can use initiative to solve problems
- Flexible approach (cross-site working is required)
- Good time management
- Ability to work independently and accept delegated responsibility
Person Specification
Qualifications & Education
Essential
- Registrant of the General Pharmaceutical Council (GPhC)
- Degree (in a scientific subject e.g., Chemistry or Pharmacy) or equivalent qualification / relevant experience
Knowledge & Experience
Essential
- Up to date knowledge and understanding of Good. Manufacturing Practice and its application
- Knowledge of Quality Assurance of Aseptic Preparation Service (QAAPS) standards including Section 10 and Regulation 37 exemptions
- Evidence of professional CPD
- Post qualification experience within the pharmacy sector
Desirable
- A wide variety of hospital pharmacy experience
- Experience of working in a GMP environment
- Knowledge of MHRA Guidance in relation to unlicensed and licensed medicines
- Knowledge of HTA regulations for the receipt, storage and distribution of cells and tissues
- Working knowledge of the preparation of advanced therapy medicinal products (ATMPs)
- Experience of managing operational activity within a pharmacy setting
- Evidence of further training in quality assurance
Skills & Abilities
Essential
- Able to work carefully and methodically
- Good keyboard and general IT skills
- Can use initiative to solve problems
- Flexible approach (cross-site working is required)
- Good time management
- Ability to work independently and accept delegated responsibility
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
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).
UK Registration
Applicants must have current UK professional registration. For further information please see
NHS Careers website (opens in a new window).
.png){kind=logo}
