Job summary
We are looking for a highly motivated and experienced Pharmacist to take on this new, exciting and developing role of Accountable Pharmacist for Advanced Therapies, trials and CIVAS based on the Guy's Hospital site.
Supported by an existing cross site team you will lead the Guy's Pharmacy Containment Suite and develop this as a stand alone aseptic unit site for the aseptic preparation of advanced therapies. You will be responsible for managing unit capacity, quality systems and supply performance and need to ensure the unit can meet effectively prioritises its resources to maximum patient benefit
You will be experienced in aseptic processing and be able to demonstrate how you have lead and motivated a production team managing demand, resource and quality in a robust manner. You will have expert knowledge and experience of GMP and be able to inspire and ensure regulatory compliance across your teams through expert knowledge, leadership and effective communication. Previous knowledge and experience of handling advanced therapies is desirable
Reflecting on your previous experience, you will be able to identify areas of development and opportunity within our serviceand communicate and champion these to your staff and wider Trust management
Its an exciting time to join aseptic services at Guy's & St Thomas with aseptic estates development planned over the next 5 years and increased demand for clinical trials, cancer treatments, CIVAS and advanced therapies.
Main duties of the job
To be the Accountable Pharmacist for aseptic preparation and dispensing of medicines from the Guy's Pharmacy Containment and Aseptic unit
To oversee and monitor the unit capacity plan and ensure activities are within the safe working levels of the unit. To implement and escalate contingency plans
To oversee the Quality Management system, monitoring metrics and enact and escalate contingency plans reporting at the monthly and quality management meeting
To oversee the management of datix reports and identification, escalation and management of risk.
To lead and be responsible for the delivery of clinical trials requiring aseptic preparation from the Guy's Pharmacy Containment and Aseptic unit for GSTT and commercial sponsored trials.
To lead on changes within the unit to progress the service development and review of new products and requests in conjunction with the Associate Chief Pharmacist.
To develop a team with the required knowledge and expertise to deliver advanced therapies to Trust patients.
About us
Guy's & St Thomas' Technical Services is split across a number of sites and involves around 140 staff working in licensed manufacturing and named patient dispensing areas. Services include sterile and non sterile manufacturing, clinical trials, quality control and quality assurance as well aseptic preparation of CIVAS and chemotherapy.
There is a wide range of expertise throughout the department and many opportunities to learn and develop from technical experts.
The Trust is going through an Aseptic Transformation programme to develop its on site and off site aseptic facilities to ensure patient need can be met over the next 10-15 years
Job description
Job responsibilities
Main duties are:
- Professional leadership
- Aseptic processing, capacity and contingency management
- Service evaluation and management
- Quality systems and risk management
- Workforce management, training and development
- Audit
- Clinical trials
- Strategic development
Job description
Job responsibilities
Main duties are:
- Professional leadership
- Aseptic processing, capacity and contingency management
- Service evaluation and management
- Quality systems and risk management
- Workforce management, training and development
- Audit
- Clinical trials
- Strategic development
Person Specification
knowledge, skills and abilities
Essential
- Demonstrated ability to undertake the day to day leadership, management, motivation and appraisal of staff
Skills, knowledge, ability
Essential
- Demonstrated practical knowledge of GCP, GMP, QA and all current regulations to enable operation at a highest level of practice
- Demonstrated ability to investigate deviations, identify levels of risk, identify root cause and develop effective corrective and preventative actions
- Demonstrated ability to reliably evaluate risk and escalate and communicate appropriately
Experience
Essential
- Previous assessable experience of effectively managing and leading an aseptic unit
- Experience of managing change and deviations within a pharmaceutical quality management system
- Previous assessable experience of managing workload and capacity and prioritising activity to ensure safe working levels
- Previous assessable experience of identifying need, developing and expanding a production service in collaboration with clinical teams and in response to service and patient needs
- Previous assessable experience of the design, installation and qualification of new production facilities and equipment
Desirable
- Experience of aseptic processing of advanced therapy products
Qualifications
Essential
- Competency assessed and examined professional registration as a pharmacist or technician with the GPhC. Mandatory CPD to maintain fitness to practice..
- Specialist higher degree (Masters) in technical services (eg National course in Pharmaceutical Technology & Quality Assurance MSc) or equivalent experience
- Registered Pharmacist with General Pharmaceutical council
Desirable
Person Specification
knowledge, skills and abilities
Essential
- Demonstrated ability to undertake the day to day leadership, management, motivation and appraisal of staff
Skills, knowledge, ability
Essential
- Demonstrated practical knowledge of GCP, GMP, QA and all current regulations to enable operation at a highest level of practice
- Demonstrated ability to investigate deviations, identify levels of risk, identify root cause and develop effective corrective and preventative actions
- Demonstrated ability to reliably evaluate risk and escalate and communicate appropriately
Experience
Essential
- Previous assessable experience of effectively managing and leading an aseptic unit
- Experience of managing change and deviations within a pharmaceutical quality management system
- Previous assessable experience of managing workload and capacity and prioritising activity to ensure safe working levels
- Previous assessable experience of identifying need, developing and expanding a production service in collaboration with clinical teams and in response to service and patient needs
- Previous assessable experience of the design, installation and qualification of new production facilities and equipment
Desirable
- Experience of aseptic processing of advanced therapy products
Qualifications
Essential
- Competency assessed and examined professional registration as a pharmacist or technician with the GPhC. Mandatory CPD to maintain fitness to practice..
- Specialist higher degree (Masters) in technical services (eg National course in Pharmaceutical Technology & Quality Assurance MSc) or equivalent experience
- Registered Pharmacist with General Pharmaceutical council
Desirable
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).
