Job summary
Hi I'm Christine, Accountable Pharmacist for the Clinical Trials Aseptic Services Unit. We are looking for a passionate and dynamic Aseptic Services Manager to join our Pharmacy Clinical Trials Aseptic Services Team for our unique and well-established facility. The role is dedicated to clinical trials and you will work as part of the wider Pharmacy Clinical Trials Team. In your new role, you will have the opportunity to use your knowledge and experience of working in aseptics in UK and build on this to deliver a range of aseptically dispensed clinical trial medicines.
If this role is of interest, then please get in touch for an informal chat and/or visit.
Main duties of the job
* To lead and manage the day to day service provided by CTAS, and ensure that aseptic preparation of medicines is run in accordance with current guidance and best practice.
* To participate in identifying and implementing initiatives as appropriate to reduce the financial costs and the environmental impact of CTAS service.
* To have a good working knowledge of Quality Assurance of Aseptic Preparation Services handbook requirements and the yellow cover guidance documents from SPS. To work with the Accountable Pharmacist and Deputy to review the impact of changes to these standards and implementing change where required.
* To have good working knowledge of the Medicines for Human Use (Clinical Trials) Regulation (EU Directive 2001/20EC), Human Medicines (EU Exit) Regulations 2019 and the International Conference on Harmonisation GCP Guideline (ICH GCP), as applicable to the dispensing of Investigational Medicinal Products for clinical trials or other products.
* To ensure the preventative maintenance and environmental monitoring program is undertaken as per SOPs, paperwork is received and reviewed and that deviations are managed to ensure compliance with the standards.
* To be responsible for the ongoing recruitment of staff, induction and management, and collaborate with the training team to ensure an effective and competent workforce.
* To ensure the CTAS and its staff operate to standards of excellence in customer care and with a strong patient focus
See attached JD for full details.
About us
Oxford University Hospitals NHS Foundation Trust is one of the largest NHS teaching trusts in the country. It provides a wide range of general and specialist clinical services and is a base for medical education, training and research. The Trust comprises four hospitals - the John Radcliffe Hospital, Churchill Hospital and Nuffield Orthopaedic Centre in Headington and the Horton General Hospital in Banbury.
Our values, standards and behaviours define the quality of clinical care we offer and the professional relationships we make with our patients, colleagues and the wider community.
We call this Delivering Compassionate Excellence, and its focus is on our values of compassion, respect, learning, delivery, improvement and excellence.
These values put patients at the heart of what we do and underpin the quality healthcare we would like for ourselves or a member of our family. Watch how we set out to deliver compassionate excellence via the OUH YouTube channel.
In 2023NHS England launched its first sexual safety charter, and our Trust proudly signed it. We pledge zero tolerance for inappropriate sexual behaviour and commit to the ten core principles
Oxford University Hospitals promotes a safe, respectful hiring environment.
If you want to make a difference with us, come and join our team. Together, we will uphold the highest standards of care and professionalism.
Job description
Job responsibilities
* To lead and manage the day to day service provided by CTAS, and ensure that aseptic preparation of medicines is run in accordance with current guidance and best practice, as detailed but not limited to those set out in Quality Assurance of Aseptic Preparation Services Handbook.
To provide cost-effective delivery of high quality aseptic pharmaceuticals, which are fit for their intended purpose to patients of the Trust, and other external customers of the service, and are prepared in a safe, efficient and cost effective manner in accordance with departmental SOPs.
To participate in identifying and implementing initiatives as appropriate to reduce the financial costs and the environmental impact of CTAS service.
To have a good working knowledge of Quality Assurance of Aseptic Preparation Services handbook requirements and the yellow cover guidance documents from SPS. To work with the Accountable Pharmacist and Deputy to review the impact of changes to these standards and implementing change where required.
* To maintain a comprehensive knowledge of national legislation and recommendations from the Department of Health, MHRA, NHS England, the General Pharmaceutical Council and Royal Pharmaceutical Society relating to aseptic preparation and Good Manufacturing Practice.
To have good working knowledge of the Medicines for Human Use (Clinical Trials) Regulation (EU Directive 2001/20EC), Human Medicines (EU Exit) Regulations 2019 and the International Conference on Harmonisation GCP Guideline (ICH GCP), as applicable to the dispensing of Investigational Medicinal Products for clinical trials or other products eg NIMPs, physiological compounds given to study subjects.
To facilitate NHS QA inspections, MHRA, sponsor audits where required, collaborating and communicating complex regulatory information to ensure that action is undertaken to resolve any findings.
To work with the Accountable Pharmacist and Deputy to maintain the Pharmaceutical Quality System (PQS), and ensure staff are working according to the Standard Operating Procedures detailed in the PQS.
Alongside the Accountable Pharmacist ensure all staff that work in CTAS are trained and competent to perform daily tasks, and that there is an ongoing validation programme in place to demonstrate ongoing competency.
To ensure the preventative maintenance and environmental monitoring program is undertaken as per SOPs, paperwork is received and reviewed and that deviations are managed to ensure compliance with the standards.
To monitor and record internal and external errors/near misses, taking corrective and preventative action if necessary, as part of the Trusts Incident Monitoring Program.
To participate as required at local, regional and/or national levels to support the continuation and advancement of Pharmacy Aseptic preparation and associated research. This may require participation at regional Aseptic Service meetings or projects.
To be responsible for the ongoing recruitment of staff, induction and management, and collaborate with the training team to ensure an effective and competent workforce.
To be aware of Health and Safety regulations, and how these apply to an aseptic unit; such as, but not limited to manual handling, First Aid, COSHH, Biocidal Products Regulation.
To be responsible for accurate financial records, including invoicing, checking of invoices and authorisation of invoices for payment.
To be responsible for ensuring that Drug Alerts received from the Medicines and Healthcare Regulatory Authority (MHRA) are processed and any actions taken within a required time frame.
To ensure the CTAS and its staff operate to standards of excellence in customer care and with a strong patient focus.
Job description
Job responsibilities
* To lead and manage the day to day service provided by CTAS, and ensure that aseptic preparation of medicines is run in accordance with current guidance and best practice, as detailed but not limited to those set out in Quality Assurance of Aseptic Preparation Services Handbook.
To provide cost-effective delivery of high quality aseptic pharmaceuticals, which are fit for their intended purpose to patients of the Trust, and other external customers of the service, and are prepared in a safe, efficient and cost effective manner in accordance with departmental SOPs.
To participate in identifying and implementing initiatives as appropriate to reduce the financial costs and the environmental impact of CTAS service.
To have a good working knowledge of Quality Assurance of Aseptic Preparation Services handbook requirements and the yellow cover guidance documents from SPS. To work with the Accountable Pharmacist and Deputy to review the impact of changes to these standards and implementing change where required.
* To maintain a comprehensive knowledge of national legislation and recommendations from the Department of Health, MHRA, NHS England, the General Pharmaceutical Council and Royal Pharmaceutical Society relating to aseptic preparation and Good Manufacturing Practice.
To have good working knowledge of the Medicines for Human Use (Clinical Trials) Regulation (EU Directive 2001/20EC), Human Medicines (EU Exit) Regulations 2019 and the International Conference on Harmonisation GCP Guideline (ICH GCP), as applicable to the dispensing of Investigational Medicinal Products for clinical trials or other products eg NIMPs, physiological compounds given to study subjects.
To facilitate NHS QA inspections, MHRA, sponsor audits where required, collaborating and communicating complex regulatory information to ensure that action is undertaken to resolve any findings.
To work with the Accountable Pharmacist and Deputy to maintain the Pharmaceutical Quality System (PQS), and ensure staff are working according to the Standard Operating Procedures detailed in the PQS.
Alongside the Accountable Pharmacist ensure all staff that work in CTAS are trained and competent to perform daily tasks, and that there is an ongoing validation programme in place to demonstrate ongoing competency.
To ensure the preventative maintenance and environmental monitoring program is undertaken as per SOPs, paperwork is received and reviewed and that deviations are managed to ensure compliance with the standards.
To monitor and record internal and external errors/near misses, taking corrective and preventative action if necessary, as part of the Trusts Incident Monitoring Program.
To participate as required at local, regional and/or national levels to support the continuation and advancement of Pharmacy Aseptic preparation and associated research. This may require participation at regional Aseptic Service meetings or projects.
To be responsible for the ongoing recruitment of staff, induction and management, and collaborate with the training team to ensure an effective and competent workforce.
To be aware of Health and Safety regulations, and how these apply to an aseptic unit; such as, but not limited to manual handling, First Aid, COSHH, Biocidal Products Regulation.
To be responsible for accurate financial records, including invoicing, checking of invoices and authorisation of invoices for payment.
To be responsible for ensuring that Drug Alerts received from the Medicines and Healthcare Regulatory Authority (MHRA) are processed and any actions taken within a required time frame.
To ensure the CTAS and its staff operate to standards of excellence in customer care and with a strong patient focus.
Person Specification
Qualifications
Essential
* Pharmacy Tech or SMT Diploma
* PIPC
Desirable
* PTQA or equivalent
Experience
Essential
* Experience in aseptic services
* experience of training and supervision
* Knowledge of and ability to apply GMP and QA to aseptic services
* Experience of managing staff
Desirable
* Experience working in Clinical Trials
* Experience working in ATMPs
Personal Skills
Essential
* Accurate in work and attention to detail
* Good time management skills
* Good problem solving skills
Behavioural
Essential
* capable of working under pressure
* ability to liaise, explain and convey difficult information and messages to all staff and service users
* ability to work in a team and independently
Person Specification
Qualifications
Essential
* Pharmacy Tech or SMT Diploma
* PIPC
Desirable
* PTQA or equivalent
Experience
Essential
* Experience in aseptic services
* experience of training and supervision
* Knowledge of and ability to apply GMP and QA to aseptic services
* Experience of managing staff
Desirable
* Experience working in Clinical Trials
* Experience working in ATMPs
Personal Skills
Essential
* Accurate in work and attention to detail
* Good time management skills
* Good problem solving skills
Behavioural
Essential
* capable of working under pressure
* ability to liaise, explain and convey difficult information and messages to all staff and service users
* ability to work in a team and independently
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.
Certificate of Sponsorship
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 .
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. .
UK Registration
Applicants must have current UK professional registration. For further information please see
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.
Certificate of Sponsorship
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 .
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. .
UK Registration
Applicants must have current UK professional registration. For further information please see
Employer details
Employer name
Oxford University Hospitals NHS Foundation Trust
Address
Clinical Trials Aseptic Services Unit (CTASU), Churchill Hospital
Old Road
Headington, Oxford
OX3 7LE
Employer's website #J-18808-Ljbffr