Principal Aseptic Services Technician
- Employer
- King's College Hospital NHS Foundation Trust
- Location
- London
- Salary
- £44,806 to £53,134 per annum incl HCA
- Closing date
- 17 Dec 2024
View more categoriesView less categories
- Profession
- Other Health Profession
- Grade
- Band 6
- Contract Type
- Permanent
- Hours
- Full Time
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The post holder will assist the Chief Pharmacy Technician and Quality Assurance Specialist in the management and development of Pharmacy Aseptic Services at Kings College Hospital NHS Trust, particularly in workforce development and operational quality management. The service includes cytotoxic chemotherapy, parenteral nutrition (PN), centralised intravenous additives (CIVAS) and Clinical Trials (CT).
Main duties of the job
The post holder will have service and supervisory responsibilities at King's College Hospital Denmark Hill site, across 2 clean room facilities.
The main roles of the post are:
Coordinate and ensure effectiveness of the training and professional development of technical staff, whilst developing the aseptic services training programme and planning for anticipated changes affecting the service or workforce.
Maintenance of the Pharmaceutical Quality System (PQS), as part of the management team.
Support managing technical staff and the technical aspects of aseptic dispensing to ensure that all products are made to the highest quality enforced by Good Manufacturing Practice (GMP)/Quality Assurance systems and applicable regulations/guidance.
About us
King's College Hospital NHS Foundation Trust is one of the UK's largest and busiest teaching Trusts with a turnover of £1 billion, 1.5 million patient contacts a year and around 15,000 staff based across 5 main sites in South East London. The Trust provides a full range of local hospital services across its different sites, and specialist services from King's College Hospital (KCH) sites at Denmark Hill in Camberwell and at the Princess Royal University Hospital (PRUH) site in Bromley.
King's is committed to delivering Sustainable Healthcare for all via our Green Plan. In line with national Greener NHS ambitions, we have set net zero carbon targets of 2040 for our NHS Carbon Footprint and 2045 for our NHS Carbon Footprint Plus .
Our values at King's, are that we're a kind, respectful team
Kind. We show compassion and understanding and bring a positive attitude to our work
Respectful. We promote equality, are inclusive and honest, speaking up when needed
Team. We support each other, communicate openly, and are reassuringly professional
King's is dedicated to embracing the broad diversity of our staff, patients and communities and stand firmly against all forms of prejudice and discrimination. This includes, but is not limited to, racism, ableism, homophobia, biphobia, transphobia, sexism, ageism, religious discrimination, and any other prejudiced behaviour that undermines the rights, wellbeing and identity of our staff, and patients.
Job description
Job responsibilities
Policy and Process
To provide a comprehensive Aseptic Service to the Trust, ensuring compliance with current directives, legislation, guidance, external audits, GMP, GCP and Health and Safety. This service includes the provision of chemotherapy, TPN, CIVAS, CT and aseptically manufactured products.
To be a part of Aseptic Services management (ASM) and advise/propose changes on policy, procedures, facilities, equipment, safety and staffing.
To communicate with all members of staff regarding aseptically prepared products and to provide advice where appropriate.
Support the development of the PQS and PQS processes, including ownership of quality management processes.
To review and revise documentation within Aseptic Services ensuring compliance with current directives relating to cGMP and Health and Safety. This includes reviewing records and reports concerning the environmental monitoring programme and operational status of the cleanrooms, and the calibration/maintenance status of operational and monitoring equipment.
To be involved in managing and delivering the internal QA audit programme and to contribute to external audit readiness.
To ensure the environmental monitoring programme, operator validation status, and the calibration status of operational/monitoring equipment is compliant and maintained.
To review and trend the environmental monitoring programme (cleanroom and associated equipment), errors and other KPIs, as required.
To contribute to investigations concerning deviations, temperature monitoring issues, and other incidents.
To be a champion for cGMP within Aseptic Services and the wider department.
To deputise for management staff concerning day-to-day operations, quality management, and training of technical staff.
People Management /Performance
Lead, coach and manage the performance of the team in line with good people management practices, ensuring excellence is recognised and underperformance is addressed.
To provide expertise on systems and processes for the management of the Aseptic Services.
To be a line manager for technical staff and take responsibility for all the following, according to all Trust procedures: such as Disciplinary, Probation, and Departmental workload allocations.
Participate in regular performance appraisal meetings and ensure each member of the team has a clear set of objectives and development plans.
Ensuring safe and efficient working and supporting staff to ensure they are fit for work and workload is distributed appropriately.
Ensure the team is compliant with all statutory, mandatory training together with any professional training requirements, ensuring they are up to date and fully compliant.
Manage team absences including sickness in line with Trust policy ensuring the appropriate return to work meetings occur, e-roster is updated and productivity is kept to the highest possible level.
Identify and fill any vacancies that arise within the team in line with the Trusts recruitment policy and process.
Identify talent and support the internal talent management process in order to attract and retain staff, as well as succession planning for your people.
Review skill mix at regular intervals in order to identify any potential opportunities to maximise resource utilisation / allocation, ensuring job descriptions are kept up to date.
Ensure overall wellbeing of the team is maintained. Continuously support in improving the morale of the team and implementing a culture of zero-tolerance for bullying and harassment.
Education and Training
To coordinate and review practical training, training refreshers (i.e. GMP), and completion of training manuals.
To develop, coordinate and deliver competency-based training to all staff working within Aseptic Services and to ensure this training is documented on individual training records according to GMP.
To observe practice and identify training and development needs for individual members of staff.
To ensure planned feedback meetings for rotational staff and students are completed and compliant with their schedule.
To be a Practice Supervisor to technical staff and an Education Supervisor for Level 2 Qualification students.
To coordinate and be the point-of-call regarding work-experience placements within Aseptic Services.
To take personal responsibility for own professional growth and to develop agreed action plan with the responsible manager.
To maintain own professional competence, credibility and CPD, ensuring that knowledge is continually updated in the field of Aseptic Services.
To adhere to relevant Professional Code of Conduct at all times.
Delivery of training to stakeholders.
Integrate organisation-wide working groups related to workforce development, as required.
Operational Performance
To be able to undertake aseptic preparation of cytotoxic drugs, CIVAS products, clinical trials and parenteral nutrition to the patients of Kings College Hospital according to the cGMP, QAAPS, Guidance on Aseptic dispensing for NHS Patients, Health and Safety at Work Act and departmental procedures.
To perform pre- and in-process checking for aseptic preparation of all products.
To undergo accreditation as a Pharmacy Product Approver and accurately check prepared products.
To contribute to the day-to-day management of the cleanroom and staffing, when required.
To release outsourced unlicensed products purchased by Aseptic Services.
To ensure errors are reported accurately and timely, as per the National Error Reporting Scheme and QAAPS.
To assist the Lead Technician in managing and troubleshooting stock management activities/issues, particularly high-cost medicines.
Research and Service Development
To support and be a key member for R& D activities with a view to improving national and international practice, and showcasing Kings Services.
Person Specification
Education and Qualifications
Essential
Desirable
Knowledge and Experience
Essential
Desirable
Skills and Competencies
Essential
Employer details
Employer name
King's College Hospital NHS Foundation Trust
Address
King's College Hospital
Denmark Hill
London
SE5 9RS
Any attachments will be accessible after you click to apply.
213-CAY-6835573
Main duties of the job
The post holder will have service and supervisory responsibilities at King's College Hospital Denmark Hill site, across 2 clean room facilities.
The main roles of the post are:
Coordinate and ensure effectiveness of the training and professional development of technical staff, whilst developing the aseptic services training programme and planning for anticipated changes affecting the service or workforce.
Maintenance of the Pharmaceutical Quality System (PQS), as part of the management team.
Support managing technical staff and the technical aspects of aseptic dispensing to ensure that all products are made to the highest quality enforced by Good Manufacturing Practice (GMP)/Quality Assurance systems and applicable regulations/guidance.
- The Principal Aseptic Services Technician has the responsibility of assisting in developing the Pharmacy Aseptic Service in line with NHS priorities. They will work alongside the Aseptic Services management and quality teams at KCH, providing professional leadership and advice on matters. This may include strategic development of services, workforce development and planning, as well as working at a regional level.
- All work will be carried out according to procedures and standards of professional practice in the department however, staff are expected to develop their own safe systems of work to ensure a high professional standard of work conducive to patient safety.
About us
King's College Hospital NHS Foundation Trust is one of the UK's largest and busiest teaching Trusts with a turnover of £1 billion, 1.5 million patient contacts a year and around 15,000 staff based across 5 main sites in South East London. The Trust provides a full range of local hospital services across its different sites, and specialist services from King's College Hospital (KCH) sites at Denmark Hill in Camberwell and at the Princess Royal University Hospital (PRUH) site in Bromley.
King's is committed to delivering Sustainable Healthcare for all via our Green Plan. In line with national Greener NHS ambitions, we have set net zero carbon targets of 2040 for our NHS Carbon Footprint and 2045 for our NHS Carbon Footprint Plus .
Our values at King's, are that we're a kind, respectful team
Kind. We show compassion and understanding and bring a positive attitude to our work
Respectful. We promote equality, are inclusive and honest, speaking up when needed
Team. We support each other, communicate openly, and are reassuringly professional
King's is dedicated to embracing the broad diversity of our staff, patients and communities and stand firmly against all forms of prejudice and discrimination. This includes, but is not limited to, racism, ableism, homophobia, biphobia, transphobia, sexism, ageism, religious discrimination, and any other prejudiced behaviour that undermines the rights, wellbeing and identity of our staff, and patients.
Job description
Job responsibilities
Policy and Process
To provide a comprehensive Aseptic Service to the Trust, ensuring compliance with current directives, legislation, guidance, external audits, GMP, GCP and Health and Safety. This service includes the provision of chemotherapy, TPN, CIVAS, CT and aseptically manufactured products.
To be a part of Aseptic Services management (ASM) and advise/propose changes on policy, procedures, facilities, equipment, safety and staffing.
To communicate with all members of staff regarding aseptically prepared products and to provide advice where appropriate.
Support the development of the PQS and PQS processes, including ownership of quality management processes.
To review and revise documentation within Aseptic Services ensuring compliance with current directives relating to cGMP and Health and Safety. This includes reviewing records and reports concerning the environmental monitoring programme and operational status of the cleanrooms, and the calibration/maintenance status of operational and monitoring equipment.
To be involved in managing and delivering the internal QA audit programme and to contribute to external audit readiness.
To ensure the environmental monitoring programme, operator validation status, and the calibration status of operational/monitoring equipment is compliant and maintained.
To review and trend the environmental monitoring programme (cleanroom and associated equipment), errors and other KPIs, as required.
To contribute to investigations concerning deviations, temperature monitoring issues, and other incidents.
To be a champion for cGMP within Aseptic Services and the wider department.
To deputise for management staff concerning day-to-day operations, quality management, and training of technical staff.
People Management /Performance
Lead, coach and manage the performance of the team in line with good people management practices, ensuring excellence is recognised and underperformance is addressed.
To provide expertise on systems and processes for the management of the Aseptic Services.
To be a line manager for technical staff and take responsibility for all the following, according to all Trust procedures: such as Disciplinary, Probation, and Departmental workload allocations.
Participate in regular performance appraisal meetings and ensure each member of the team has a clear set of objectives and development plans.
Ensuring safe and efficient working and supporting staff to ensure they are fit for work and workload is distributed appropriately.
Ensure the team is compliant with all statutory, mandatory training together with any professional training requirements, ensuring they are up to date and fully compliant.
Manage team absences including sickness in line with Trust policy ensuring the appropriate return to work meetings occur, e-roster is updated and productivity is kept to the highest possible level.
Identify and fill any vacancies that arise within the team in line with the Trusts recruitment policy and process.
Identify talent and support the internal talent management process in order to attract and retain staff, as well as succession planning for your people.
Review skill mix at regular intervals in order to identify any potential opportunities to maximise resource utilisation / allocation, ensuring job descriptions are kept up to date.
Ensure overall wellbeing of the team is maintained. Continuously support in improving the morale of the team and implementing a culture of zero-tolerance for bullying and harassment.
Education and Training
To coordinate and review practical training, training refreshers (i.e. GMP), and completion of training manuals.
To develop, coordinate and deliver competency-based training to all staff working within Aseptic Services and to ensure this training is documented on individual training records according to GMP.
To observe practice and identify training and development needs for individual members of staff.
To ensure planned feedback meetings for rotational staff and students are completed and compliant with their schedule.
To be a Practice Supervisor to technical staff and an Education Supervisor for Level 2 Qualification students.
To coordinate and be the point-of-call regarding work-experience placements within Aseptic Services.
To take personal responsibility for own professional growth and to develop agreed action plan with the responsible manager.
To maintain own professional competence, credibility and CPD, ensuring that knowledge is continually updated in the field of Aseptic Services.
To adhere to relevant Professional Code of Conduct at all times.
Delivery of training to stakeholders.
Integrate organisation-wide working groups related to workforce development, as required.
Operational Performance
To be able to undertake aseptic preparation of cytotoxic drugs, CIVAS products, clinical trials and parenteral nutrition to the patients of Kings College Hospital according to the cGMP, QAAPS, Guidance on Aseptic dispensing for NHS Patients, Health and Safety at Work Act and departmental procedures.
To perform pre- and in-process checking for aseptic preparation of all products.
To undergo accreditation as a Pharmacy Product Approver and accurately check prepared products.
To contribute to the day-to-day management of the cleanroom and staffing, when required.
To release outsourced unlicensed products purchased by Aseptic Services.
To ensure errors are reported accurately and timely, as per the National Error Reporting Scheme and QAAPS.
To assist the Lead Technician in managing and troubleshooting stock management activities/issues, particularly high-cost medicines.
Research and Service Development
To support and be a key member for R& D activities with a view to improving national and international practice, and showcasing Kings Services.
Person Specification
Education and Qualifications
Essential
- NVQ Pharmacy services Level 3 plus accredited underpinning knowledge (BTEC in Pharmaceutical Sciences or equivalent) or equivalent plus Professional registration as a Pharmacy Technician with the General Pharmaceutical Council OR Completion of Science Manufacturing Technician Level 3 apprenticeship in a pharmaceutical setting, plus registration as a Science Technician with a relevant professional body (i.e. Royal Society of Chemistry or Royal Society of Biology) OR Academic qualification (at least BSc) related to pharmaceutical science and medicines for Human Use, plus professional registration with a relevant professional body (i.e. Royal Pharmaceutical Society or Health and Care Professions Council).
Desirable
- Training and/or Quality Management qualification or course
- Leadership/management qualification or course
- Pre and In-Process Check accreditation (PIPC)
Knowledge and Experience
Essential
- Significant knowledge of cGMP, Pharmaceutical Quality Systems and regulations/legislation relevant to Aseptic Services.
- Experience in quality management processes such as, deviations, change controls, and/or CAPA.
- Experience in a training and supervisory capacity, at an Aseptic Services setting
- Practical and theoretical knowledge/experience in aseptic processing/techniquesfor the preparation of cytotoxic, monoclonal antibodies, and clinical trials products, and associated risks.
Desirable
- Experience in line managing and coaching junior staff
Skills and Competencies
Essential
- Be able to communicate professionally and effectively in both written and verbal formats
Employer details
Employer name
King's College Hospital NHS Foundation Trust
Address
King's College Hospital
Denmark Hill
London
SE5 9RS
Any attachments will be accessible after you click to apply.
213-CAY-6835573
You need to sign in or create an account to save a job.
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