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Aseptic, Quality Assurance

2 months ago

Sutton, United Kingdom The Royal Marsden Full time

Job overview

 Band 6 & 7s Aseptic, Quality Assurance & Clinical Trial Pharmacist
Location: Sutton (Expected to provide cross-site coverage if needed)

A fantastic opportunity has emerged for a passionate, highly motivated, and dynamic pharmacist to join the pharmacy aseptic and pharmacy clinical trials team at the Royal Marsden NHS Foundation Trust.
This is an exciting time to join the Royal Marsden Hospital Clinical Trials Department. Our service is built around providing a high-quality service to our patients and staff of the Trust.

Applicants should have previous experience in aseptics or/& clinical trials, and a background in oncology or haemato-oncology would be advantageous.
You will be part of a team consisting of Pharmacists, Technicians and Assistants, who are always striving for excellence in all aspects of our work. We are working collaboratively as part of a Multi-Disciplinary Team to ensure we always deliver outstanding care to our patients.
Our team continues to support the research strategy of "taking personalized cancer treatment to the next level," with approximately 380 active IMP studies and increasingly complex new clinical trials across all specialties, including gene therapies and cellular therapies studies.

If you would like to discuss this post further, please contact: 
Lead R&D Pharmacist for Sutton, Pharmacy Dept, Myriam Bradburn or 
Deputy Aseptics Pharmacist, Rahul Kadadi 

Main duties of the job

To join the Aseptic/QA services and Clinical Trials pharmacy team at the Royal Marsden NHS Foundation Trust liaising closely with other pharmacy team members and Hospital staff.

1.1.The post holder will assist and work closely with the objectives of the senior managers across clinical trials and aseptic services.

1.3.To work with the clinical trials team and contribute to operational cover on the wards the set-up, delivery, and ongoing management for IMP studies.

1.4.To support the safe delivery to meet the demands of an unlicensed section 10 aseptic service for RMH.

Candidate will either join as a Band 6 or at a Band 7 level dependent on NHS Pharmacy Aseptics/or Clinical Trials experience or equivalent:

Detailed job description and main responsibilities

Aseptic Services

a) To assist the Aseptic Services Management team in the day-to-day management and provision of the cytotoxic reconstitution and aseptic services (including gene therapy) across sites. 

b) Ensure appropriate working conditions are adhered too and that the relevant principles of Good Manufacturing and Dispensing Practice, and those of the Health and Safety at Work Act are applied at all times. 

c) Ensure all professional aspects of technical services are incorporated into the chemotherapy and aseptic services procedure manuals and other aseptic services documentation. 

d) Ensure that aseptic services policies and procedures are adhered to, and production records and training documents are completed appropriately. 

e) To assist the Aseptic Services Management team in the delivery of local projects to optimise service provision and improve patient experience. 

f) Support the aseptic unit with any aseptic documentation that is required such as worksheet production, new product reviews, drug stability reviews and in-house drug monographs. 

f) Support the Aseptic Services Management team in working towards and maintaining quality standards

g) Participate in the chemotherapy prescription verification rota


Pharmacy Quality Assurance

a) To assist the aseptic department to ensure the service is fully compliant with the relevant regulatory guidelines.

b) Assist in maintaining the Quality Management System (QMS) in accordance with the unlicensed NHS facility requirements as documented in procedures and policies. 

c) Assist in reviewing and approving data generated from Micro testing (including verification, calibration and validation for methods and equipment/accreditation results) 

d) Supporting the Aseptic Services Management team with CAPAs and Change Controls as per Quality Assurance of Aseptic Preparation Services (QAAPS) and MHRA guidelines.

e) Assist in completion of patient impact assessments and product quality risk assessments via deviation system

f) Raise deviations to the Senior Management Team, assist in minor & major investigations and ensuring effective implementation of identified CAPAs. Support critical deviations.
g) Daily review of the Environmental Monitoring System for the facility.

Person specification

Education/Qualifications

Essential criteria

GPhC registered Pharmacist

Desirable criteria

Working towards Diploma in Pharmacy, Pharmaceutical Quality Assurance diploma/post graduate certificate or equivalent

Experience

Essential criteria

For Band 6 Level applications will be considered for those without any experience related to aseptics/clinical trials/QA.

Desirable criteria

For Band 7 Level - Candidates are expected to have significant NHS Pharmacy Aseptics/QA/Clinical Trials experience or equivalent.

Skills/Abilities/Knowledge

Essential criteria

Contribute to the team Good communication skills (written and verbal in clear English) Good presentation and problem-solving skills Awareness of current developments in pharmacy as well as technical pharmacy services Ability to use Microsoft Office applications eg. Word and Excel.

Desirable criteria

Be able to interpret and work with complex clinical trial and aseptic documents/guidelines Good leadership skills

Personal Qualities

Essential criteria

Progressive and continuing professional development

The Royal Marsden values diversity and is committed to the recruitment and retention of underrepresented minority groups. We particularly welcome applications from Black, Asian and minority ethnic candidates, LGBTQ+ candidates and candidates with disabilities.

 As a Disability Confident Employer, we are working to create a workplace that enables all staff to reach their full potential. We are committed to this because we know that greater diversity and inclusion will lead to an even greater positive impact for the people we serve.

Due to the high volumes of applications we receive, we reserve the right to close any adverts before the published closing date once we have received a sufficient number of applications. We advise you to submit your application as early as possible to prevent disappointment.

Flu Vaccination – What We Expect of our Staff

At The Royal Marsden we have an immune compromised patient population who we must protect as much as we can against the flu virus. Each year, seasonal flu affects thousands of people in the UK. Occurring mainly in winter, it is an infectious respiratory disease capable of producing symptoms ranging from those similar to a common cold, through to very severe or even fatal disease.

The wellbeing of our staff and patients is of the upmost importance to us, and it is the expectation of The Royal Marsden that all patient-facing staff have an annual flu vaccination, provided free of charge by the Trust.

Employer certification / accreditation badges

Applicant requirements

You must have appropriate UK professional registration.

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.