Job vacancy: Senior Production Operative (Clinical Trials), The Newcastle upon Tyne Hospitals NHS Foundation Trust, 317 02 Royal Victoria Infirmary

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

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.

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

Important note on completion of reference section of Application Form

All references from current and previous employers will be sought and must cover a minimum of 3 years employment. Therefore, when completing the reference section of your application form, please give the address, telephone number and work email address of each of your current/previous line managers that cover 3 years employment. Failure to complete this section may result in your application not being processed.

Candidates who are shortlisted for interview will be contacted by e-mail. You should check your SPAM folders as well as your inbox. If you have not been contacted within 4 weeks of the closing date you should assume your application has been unsuccessful.