Aseptic, Quality Assurance & Clinical Trial Pharmacist

The Royal Marsden NHS Foundation Trust

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Job summary

Band 6 & 7s Aseptic, Quality Assurance & Clinical Trial PharmacistLocation: 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 orDeputy 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.

1.2. To develop a good understanding of Quality Assurance (QA) matters including Good Manufacturing Practice (GMP) and Quality Control (QC) and in turn contribute to the development of other staff to ensure the pharmacy provides aseptically prepared medicines, fit for their intended use, at the right time.

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:

About us

The Royal Marsden NHS Foundation Trust is a world-leading cancer centre. Our role is to offer our patients the best cancer care available anywhere in the world, and to continue to make a global contribution to finding better ways of diagnosing and treating cancer. We employ over 4,500 staff in a diverse range of careers including nursing, medical, science, radiography, pharmacy, occupational therapy, finance and administrative services. We have two hospitals - one in Chelsea, London, and one in Sutton, Surrey - as well as a Medical Daycare Unit in Kingston Hospital.

At The Royal Marsden, we deal with cancer every day, so we understand how valuable life is. When people entrust their lives to us, they have the right to demand the very best. That's why the pursuit of excellence lies at the heart of everything we do.

At the heart of the hospital is our dedicated team. We offer a stimulating and dynamic working environment, a wide range of staff benefits, learning and development opportunities and clear career pathways. There are opportunities to work flexibly across a range of areas and specialities and we welcome flexible working requests from point of hire to support employees work life balance. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements.

Date posted

20 September 2024

Pay scheme

Agenda for change

Band

Band 7

Salary

£51,883 to £58,544 a year per annum

Contract

Fixed term

Duration

12 months

Working pattern

Full-time

Reference number

282-SB1246293

Job locations

The Royal Marsden Sutton

Sutton

SM2 5PT


Job description

Job 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.

Job description

Job 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

  • GPhC registered Pharmacist

Desirable

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

Experience

Essential

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

Desirable

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

Skills/Abilities/Knowledge

Essential

  • 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

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

Personal Qualities

Essential

  • Progressive and continuing professional development
Person Specification

Education/Qualifications

Essential

  • GPhC registered Pharmacist

Desirable

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

Experience

Essential

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

Desirable

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

Skills/Abilities/Knowledge

Essential

  • 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

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

Personal Qualities

Essential

  • Progressive and continuing professional development

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.

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.

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

The Royal Marsden NHS Foundation Trust

Address

The Royal Marsden Sutton

Sutton

SM2 5PT


Employer's website

https://www.royalmarsden.nhs.uk/working-royal-marsden (Opens in a new tab)

Employer details

Employer name

The Royal Marsden NHS Foundation Trust

Address

The Royal Marsden Sutton

Sutton

SM2 5PT


Employer's website

https://www.royalmarsden.nhs.uk/working-royal-marsden (Opens in a new tab)

For questions about the job, contact:

Deputy Lead Aseptic Pharmacist

Rahul Khadadi

Rahul.kadadi@rmh.nhs.uk

Date posted

20 September 2024

Pay scheme

Agenda for change

Band

Band 7

Salary

£51,883 to £58,544 a year per annum

Contract

Fixed term

Duration

12 months

Working pattern

Full-time

Reference number

282-SB1246293

Job locations

The Royal Marsden Sutton

Sutton

SM2 5PT


Supporting documents

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