Job summary
Aseptic/QA and Clinical Trial Pharmacist Band 7 or (Band 6 to 7 Progression)
Sutton Based (Expected to cover cross site if needed)
A unique opportunity has arisen for an enthusiastic, highly motivated, dynamic pharmacist to join the pharmacy aseptic and clinical trials team at the Royal Marsden NHS Foundation Trust.
We are not specifically seeking any prior experience for this role although it is desirable, we can support training. However, you will need to demonstrate your ability to be able to work efficiently as a releasing pharmacist within a busy production unit, be able to support on quality assurance and also work with the clinical trials team in setting up and delivering a busy, cutting edge research portfolio.
We will be interested in your ability to show drive, ambition, willingness to learn, manage busy workloads, organisational and team working skills. The Royal Marsden is a world-leading cancer centre. It has two hospitals: one in Chelsea, London and the other in Sutton, Surrey. The Royal Marsden, in association with its partner, The Institute of Cancer Research, has an unrivalled worldwide reputation for patient care, research and education.
If you would like to discuss this post further, please contact:
Lead Aseptic PharmacistEric.Chan@rmh.nhs.ukor phone 0208 642 6011 ext. 4365. or Lead Trials Pharmacistilves.sanna@rmh.nhs.ukor phone 0208 642 6011 ext 4799
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.
- The post holder will assist and work closely with the objectives of the senior managers across clinical trials and aseptic services.
- 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.
- To work with the clinical trials team and contribute to the set-up, delivery, and ongoing management for IMP studies.
- To support the safe delivery to meet the demands of an unlicensed section 10 aseptic service for RMH.
Band 6 to 7 Progression
Candidate will either join on a Band 6 to 7 progression or at a Band 7 level. The criterion/objectives for meeting Band 7 are:
- Significant NHS Pharmacy Aseptics/Clinical Trials experience or equivalent.
- Be able to demonstrate competency in the releasing pharmacist role, be able to independently manage and deal with day to day operations of an unlicensed aseptic unit and also have significant experience and understanding of Aseptic QA management.
- Be able to demonstrate competency in risk assessing and setting up clinical trials, be able to independently manage study queries and process amendments.
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 and learning and development opportunities. We are looking for employees who aspire to excellence, share our values and can play a crucial role in our on-going achievements.
Job description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification.
Aseptic Services
- 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.
- 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.
- Ensure all professional aspects of technical services are incorporated into the chemotherapy and aseptic services procedure manuals and other aseptic services documentation.
- Ensure that aseptic services policies and procedures are adhered to, and production records and training documents are completed appropriately.
Pharmacy Quality Assurance
- To assist the aseptic department to ensure the service is fully compliant with the relevant regulatory guidelines.
- Assist in maintaining the Quality Management System (QMS) in accordance with the unlicensed NHS facility requirements as documented in procedures and policies, aid in development in response to changes to regulations and legislation and help improve production processes.
- Assist in reviewing and approving data generated from Micro testing (including verification, calibration and validation for methods and equipment/accreditation results)
- Supporting the Aseptic Services Management team with CAPAs and Change Controls as per Quality Assurance of Aseptic Preparation Services (QAAPS) and MHRA guidelines.
- Assist in completion of patient impact assessments and product quality risk assessments via deviation system
- Raise deviations in the QMS, assist in minor & major investigations and ensuring effective implementation of identified CAPAs. Support critical deviations.
Clinical Trials
- Supporting the clinical trial dispensing service across both sites on a daily basis and working with the pharmacy clinical trial team.
- Ensure Compliance with European and UK legislation, Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP)
- Ensure safe dispensing practices are applied and adhered to at all times when dispensing, checking and preparing clinical trial IMPs and supportive care.
- Appropriately manage and resolve any clinical queries with regards to patients trial prescriptions to maintain high standard of patient care.
General Duties and Responsibilities
- To gain working knowledge of the aseptic/QA and clinical trial sections of the pharmacy and therefore be able to work competently and with minimum supervision in any section as and when required to do so.
- To assist in the training and accreditation of trainee pharmacists, pharmacists, technicians and other health care professionals, and in the induction of all new staff.
- To act as a mentor and provide advice to junior members of the team and assist in their professional and personal development
- To participate in all department rotas, weekend service and on-call. Pharmacy is in a transitional period and moving over to a 7-day service, therefore any successful candidate would be required to participate in a 7-day service which includes requirement to work weekends, late shifts and bank holidays.
- To undertakes any other duties consistent with the nature of the post, which may vary from time to time, as requested by the pharmacy manager.
Job description
Job responsibilities
For further information on this role, please see the attached detailed Job Description and Person Specification.
Aseptic Services
- 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.
- 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.
- Ensure all professional aspects of technical services are incorporated into the chemotherapy and aseptic services procedure manuals and other aseptic services documentation.
- Ensure that aseptic services policies and procedures are adhered to, and production records and training documents are completed appropriately.
Pharmacy Quality Assurance
- To assist the aseptic department to ensure the service is fully compliant with the relevant regulatory guidelines.
- Assist in maintaining the Quality Management System (QMS) in accordance with the unlicensed NHS facility requirements as documented in procedures and policies, aid in development in response to changes to regulations and legislation and help improve production processes.
- Assist in reviewing and approving data generated from Micro testing (including verification, calibration and validation for methods and equipment/accreditation results)
- Supporting the Aseptic Services Management team with CAPAs and Change Controls as per Quality Assurance of Aseptic Preparation Services (QAAPS) and MHRA guidelines.
- Assist in completion of patient impact assessments and product quality risk assessments via deviation system
- Raise deviations in the QMS, assist in minor & major investigations and ensuring effective implementation of identified CAPAs. Support critical deviations.
Clinical Trials
- Supporting the clinical trial dispensing service across both sites on a daily basis and working with the pharmacy clinical trial team.
- Ensure Compliance with European and UK legislation, Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP)
- Ensure safe dispensing practices are applied and adhered to at all times when dispensing, checking and preparing clinical trial IMPs and supportive care.
- Appropriately manage and resolve any clinical queries with regards to patients trial prescriptions to maintain high standard of patient care.
General Duties and Responsibilities
- To gain working knowledge of the aseptic/QA and clinical trial sections of the pharmacy and therefore be able to work competently and with minimum supervision in any section as and when required to do so.
- To assist in the training and accreditation of trainee pharmacists, pharmacists, technicians and other health care professionals, and in the induction of all new staff.
- To act as a mentor and provide advice to junior members of the team and assist in their professional and personal development
- To participate in all department rotas, weekend service and on-call. Pharmacy is in a transitional period and moving over to a 7-day service, therefore any successful candidate would be required to participate in a 7-day service which includes requirement to work weekends, late shifts and bank holidays.
- To undertakes any other duties consistent with the nature of the post, which may vary from time to time, as requested by the pharmacy manager.
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.
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).
