Job summary
- Main area
- 317 Pharmacy Production Unit - RVI
- Grade
- PPU Range 3
- Contract
- Fixed term: 30 months (from date of appointment)
- Hours
- Part time - 22.5 hours per week
- Job ref
- 317-2024-32-027
- Employer
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
- Employer type
- NHS
- Site
- Royal Victoria Infirmary
- Town
- 317 02 Royal Victoria Infirmary
- Salary
- £24,071 - £25,674 pro rata
- Salary period
- Yearly
- Closing
- 05/09/2024 23:59
- Interview date
- 30/09/2024
Employer heading
![The Newcastle upon Tyne Hospitals NHS Foundation Trust logo](https://static.trac.jobs/employer-logos/168.png)
Senior Production Operative (Clinical Trials)
PPU Range 3
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 1.84 million patients ‘contacts’ each year, delivering high standards of healthcare.
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.
Newcastle Hospitals are proud to be one of the exemplar organisations across the NHS on sustainability, with a long history of delivering Sustainable Healthcare in Newcastle (Shine) and the first healthcare organisation in the world to declare a climate emergency. Our strategy includes commitments to being Net Zero by 2030, for our direct carbon footprint, and Net Zero by 2040 for our footprint plus. Delivering these ambitions will not be possible without the help, support and action of every single member of our team.
Job overview
The Newcastle upon Tyne Hospitals NHS Foundation Trust currently has approximately 90 on-going studies involving aseptically prepared investigational medicinal products (IMPs) and the Pharmacy Production Unit has an important role in ensuring that clinical trial medications are prepared safely. The Pharmacy Production Unit (Newcastle Specials) is also a licenced manufacturing unit, which manufactures Investigational Medicinal Products for a range of external clients. An exciting opportunity has arisen for an enthusiastic and well-motivated Senior Production Operative (Clinical Trials) to join the Pharmacy Production Unit Clinical Trials Team. You will provide support in order to maintain a high level Trust-wide Pharmacy Clinical Trials Service.
You will be required to communicate with professionals both internal and external to the Trust via telephone, e-mail and face-to-face. You will manage ordering, maintenance, distribution, destruction (where applicable) and return (where applicable) clinical trials products. You will also maintain Clinical Trial documentation, and produce Notification of Debts (NODs).
- Interview Date Monday, 30 September 2024
- 22 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
As well as in-house training within the Pharmacy Production Unit, you will be required to complete a Good Clinical Practice (GCP) course (online) and subsequent refreshers courses every three years. Candidates will also be required to work in the Production Unit from time to time, to manufacture Investigational Medicinal Products (IMPs) for external clients.
You will be based at Newcastle Specials, the Royal Victoria Infirmary. However, you may be required to work at the NCCC Cytotoxic unit from time to time. You will report to the Section Lead for Clinical Trials and you will be accountable to the Senior Production Pharmacist for Clinical Trials.
Candidates must be able to demonstrate good oral and written communication, have basic computer skills and be capable of working with minimum supervision.
Working for our organisation
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.
Detailed job description and main responsibilities
- To support the Pharmacy Production Unit (PPU) Clinical trials Team with implementation and maintenance of various clinical trial projects.
- To provide comprehensive administrative and organisational support to the PPU Clinical Trials Team.
- To answer telephone enquiries from internal or external persons involved in clinical trials.
- To liaise and communicate regularly with members of other disciplines working in the Trust.
- To manage ordering, maintenance, distribution, destruction (where applicable) and return (where applicable) clinical trials products.
- To maintain clinical trial documentation in PPU clinical trial files.
- To complete and maintain in house clinical trial activity monitoring records.
- To work in compliance with European and UK legislation related to clinical trials in particular Good Clinical Practice (GCP).
- To work in compliance with local health and safety rules to ensure a safe working environment for you, colleagues and visitors. To adhere to department and Trust Health and Safety policies (including COSHH, Risk assessments and Standard Operating Procedures) and to report any non-compliances to a senior member of staff.
- Calculates monies owed for previously agreed contracted clinical trial activities for approval by clinical trial Sponsors.
- Deals with finance queries from external organisations and Trust finance department.
- Organises and prepares internal notification of debt documentation for monies owed.
- Resolves queries relating to invoicing and monies owed.
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 month’s pay.
Person specification
Qualifications & Education
Essential criteria
- GCSE (Min. Grade 4 or equivalent) in Mathematics and English Language or previous hospital pharmacy production experience
- GPhC approved level 2 qualification specific to the role or must commence study within 6 months of appointment
- Must meet General Pharmaceutical Council guidelines which states pharmacy support staff must be able to demonstrate knowledge and understanding of the duties carried out within the role by having or undertaking NVQ Level 2 qualification in Pharmacy Services skills. This qualification must commence within 6 months of appointment
Desirable criteria
- GCSE Chemistry and Biology or Dual Award Science
- Completion of in-house competency-based training
- Completion of in-house validation for label production
- Completion of in-house validation for visual checking
Knowledge & Experience
Essential criteria
- Experience of dispensing and/or manufacturing clinical trial products
- Up to date knowledge of legislation and guidance relating to aseptic preparation of injectable medicines and Good Manufacturing Practice (GMP) and clinical trial legislation, e.g. Good Clinical Practice
- Up to date knowledge of manufacturing legislation and procedures, e.g. Good Manufacturing Practice, pre-packing, extemporaneous dispensing and quality assurance
- Knowledge of unlicensed aseptic preparation and the Medicines Act Section 10 exemption
- Practical experience in the start-up, maintenance and completion of a clinical trials supported by PPU
- Provision of adequate documentation and communication with the relevant people involved
- Knowledge of environmental monitoring
- Awareness of the importance of Health and Safety in the workplace
- Experience of working in a clean room environment
- Experience of working in a busy environment
Desirable criteria
- Theoretical knowledge and practical experience of Good Manufacturing Practice
- Awareness of COSHH in the workplace
- Demonstrate an up-to-date knowledge of Clinical Trial legislation
- Knowledge of pharmaceutical preparation, manufacture and aseptic processing of clinical trials
- Experience in a pharmaceutical production environment
- Experience of working in a hospital pharmacy environment
- Practical experience of working within Clinical Trials
Skills & Abilities
Essential criteria
- General keyboard skills
- Basic training skills
- Effective organisational skills
- Good written and oral communication skills
- Good customer care skills
- Able to manage own workload and use own initiative
- Ability to work accurately
Desirable criteria
- An ability to follow written standard operating procedures
- Experience of multidisciplinary communication
Documents to download
Further details / informal visits contact
- Name
- Nicole McIntyre
- Job title
- Senior Production Pharmacist - Clinical Trials
- Email address
- [email protected]
- Telephone number
- 01912820931
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