Job summary
Presenting a great opportunity for an experienced Pharmacy Technician with aseptic manufacture and quality assurance background. Are you interested in joining a CQC 'Outstanding' rated organisation that is ranked as a CHKS top 40 hospital, is in a strong financial position and consistently scores highly in the National NHS Staff Survey?
The friendly supportive team at South Warwickshire University NHS Foundation Trust are looking for a Lead Aseptic Pharmacy Technician for Quality Assurance. As the successful candidate, you will join our established quality management team in this integral role; leading on monitoring and ensuring the quality of our clean rooms, products and processes in our licensed manufacturing unit. You will be involved in the reviewing and trending of key quality data, investigating deviations and implementing change.
The Cancer and Aseptics team support two busy treatment suites and external hospitals through our manufacturing license.
To apply for this role, you must already hold GPhC registration as a Pharmacy Technician in the UK. Full training and support will be provided for the right candidate.
Main duties of the job
Reporting to the Principal Pharmacist and working closely with the Quality Lead for the Aseptic Unit, will ensure comprehensive quality systems are developed, implemented, monitored and actioned to provide a safe, high quality, and effective production service to patients and customers. The post holder will ensure compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and, where appropriate, Good Clinical Practice (GCP) requirements as well as any other applicable statutory and professional requirements.
To provide technical pharmacy services in order to improve the quality of patient care, this includes the provision of:
- Undertake QA activities such as;
- Physical and environmental monitoring of specialist clean room environments, including production of monitoring reports
- Quality assessments of products manufactured in-house and purchased for use in the Trust
- Provide technical pharmacy advice to external NHS and private healthcare customers and colleagues with regards to the quality of medicines, and safe cleanroom management
- Provide and receive complex information about prescribed medicines and cleanroom operations
- Work according to EU GMP as stated in Rules and Guidance for Pharmaceutical Manufacturers and Distributors
- Ensure that all activities within the area of work comply with departmental procedures
About us
Come and join a Trust rated Outstanding by the CQC. South Warwickshire University NHS Foundation Trust have been rated as outstanding following our latest inspection by the CQC and we are recruiting new staff to come and help us improve even further. In addition our staff survey results have placed us 4th in the country for recommended place to work.
We provide services across Warwickshire and beyond ranging from Hospitals in Warwick, Stratford-Upon-Avon, Royal Leamington Spa and Shipston-on Stour to Community Services across the county. We are a progressive, expanding organisation with great ambition around improving quality, integrating pathways and delivering high levels of productivity.
Our values can be summed up in one sentence. We are 'Trusted to provide safe, inclusive, effective and compassionate care'. Throughout the recruitment process you will be asked to think about how you demonstrate these values and how they impact on your work. It doesn't matter what role you do, whether it is patient facing or not, we are all working in the same way with our values at the core.
Job description
Job responsibilities
Measurable Result Areas
- Maintain the QMS spreadsheets
- Assist in the development, implementation and maintenance of an effective Quality Management System.
- Participate in relevant document control and policy writing.
- Participate in routine communication with external QC contractors.
- Supervise and monitor routine pharmacy quality assurance activities, environmental monitoring, facility and equipment validation and planned preventative maintenance.
- Supervise and monitor the procurement and storage of raw materials, components, consumables and final products within the Aseptic Unit.
- To undertake physical and environmental monitoring of specialist clean room environments, including production of monitoring reports
- Interpret monitoring results and report quality concerns to the Accountable Pharmacist/Production Manager and Quality Lead.
- Participate in the reporting of near misses, deviations and complaints, with the subsequent generation and investigation of reports under the supervision of the Quality Lead.
- To trend and feedback to the National Aseptic Errors Reporting Scheme (NAERS) under the supervision of the Quality Lead.
- To respond appropriately to drug alerts and product defects (medicines and consumables) by participating in the reporting of recalls and complaints and the subsequent investigation under the supervision of the Quality Lead.
- Participating in the change control process and the subsequent generation and investigation of reports under the supervision of the Quality Lead.
- Participate in Quality Assurance (QA) audits and the implementation of actions required to address deficiencies
- Participate in the MHRA Licensed inspections and closure of items on the resulting action plan.
- Participate in the Farwell Audits and closure of items on the resulting action plan.
- Undertake validation activities as required
- Develop own knowledge of GMP and QA and participate in staff training, development and accreditation.
- Identify cost pressures on QA services and advise on options for dealing with them.
- Maintain PQ folders
- To take part in completing and actioning CAPAs where needed.
- Review ongoing costs of the environmental monitoring and staff validation programmes and identify potential cost savings.
- Identify areas of development for the Quality Assurance service
- Source stability information for new products in line with Yellow Cover Document requirements, for review by the Quality Lead.
- Be familiar with and apply knowledge of COSHH and Health and Safety regulation.
- Promote and support the development and implementation of evidence-based practice for all staff.
- Develop and coordinate activities relating to Pharmacy key performance indicators including a program and schedule of audits to monitor performance and adherence to Policies and Procedures.
- Promote and maintain effective communication as well as disseminate information related to practice development.
- Check microbiological plates and provide advice with regards to the results.
- Follow Standard Operating Procedures and all relevant regulations in the course of duties.
- Inspect, assess and release products produced by the licensed manufacturing unit.
- Investigate any temperature monitoring deviations and trend analysis of medicines storage.
- Work independently within the constraints of your abilities
- Undertake quality assessments of products manufactured in-house and purchased for use in the Trust.
- Undertake risk assessments where required.
- Support the COSHH Specialist Adviser with COSHH assessments, training and administration.
- Work within Trust and local policies and procedures and to report any non-compliance to the Principal Technician Technical Services or Principal Pharmacist Cancer and Aseptic Services
- To be responsible for the day to day management of equipment and clean room device maintenance and testing. This will include:
- planned preventative maintenance,
- equipment calibration,
- troubleshooting and remedial action,
- maintaining an equipment & device fault register and prioritising workload,
- provision of reports and recommendations,
- liaison with external service contractors
- witnessing of validation, maintenance and testing.
- Maintain a clean and tidy environment and abide by the policies on security of drugs and premises and on the confidentiality of patients and staff.
- Meet the required commitment to personal CPD through continuing education and attendance at appropriate courses and study days.
- Maintain aseptic manipulation skills so as to be aware of issues, to understand the background and participate in the Aseptic rota.
- Set up validation processes for any new projects.
- Participate in the development, implementation and monitoring of aseptic pharmacy practice standards, guidelines, protocols, policies and QA SOPs.
- Provide input to ad hoc initiatives and projects as required.
- To undertake any training necessary for the safe and efficient performance of duties.
- To deliver training to other teams within aseptics where appropriate (e.g. GMP, COSHH)
- To participate in the supervision, training and mentoring of pharmacy support workers, pre-registration trainee pharmacy technicians, pre-registration pharmacists and trainees.
Supervises
Professional / Clinical responsibilities
- Maintain an active and compliant programme of CPD in accordance with hospital guidelines or relevant professional registration body.
- Work with relevant pharmacy staff in managing stock.
- Any other duties commensurate with the role or at the request of the Pharmacy Director and/or Pharmacy Operations Manager.
Education/Qualifications
- Pharmacy Technician registered with General Pharmaceutical Council (GPhC)
- Further training or qualifications in QA/QC
- Current certified GCP training
- Evidence of on-going professional development
- NVQ level 3/BTEC in Pharmaceutical Sciences or equivalent OR A level (or equivalent) science or maths qualification(s)
- GCSEs (or equivalent) in Maths and English
Competencies (Complexity of Work):
- Ability to produce clear, concise and well-articulated presentations
- Ability to undertake analysis of large or complex datasets
- Ability to critically analyse complex and difficult situations and apply problem-solving skills
- Critical thinking skills, decisive judgment and the ability to work with minimal supervision
- Ability to work in a pressurized environment and take appropriate action
- Experience analysing large or complex data sets and of using extraction tools
- Excellent analytical, verbal and written communication skills
- Reasonable understanding of Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP)
Job description
Job responsibilities
Measurable Result Areas
- Maintain the QMS spreadsheets
- Assist in the development, implementation and maintenance of an effective Quality Management System.
- Participate in relevant document control and policy writing.
- Participate in routine communication with external QC contractors.
- Supervise and monitor routine pharmacy quality assurance activities, environmental monitoring, facility and equipment validation and planned preventative maintenance.
- Supervise and monitor the procurement and storage of raw materials, components, consumables and final products within the Aseptic Unit.
- To undertake physical and environmental monitoring of specialist clean room environments, including production of monitoring reports
- Interpret monitoring results and report quality concerns to the Accountable Pharmacist/Production Manager and Quality Lead.
- Participate in the reporting of near misses, deviations and complaints, with the subsequent generation and investigation of reports under the supervision of the Quality Lead.
- To trend and feedback to the National Aseptic Errors Reporting Scheme (NAERS) under the supervision of the Quality Lead.
- To respond appropriately to drug alerts and product defects (medicines and consumables) by participating in the reporting of recalls and complaints and the subsequent investigation under the supervision of the Quality Lead.
- Participating in the change control process and the subsequent generation and investigation of reports under the supervision of the Quality Lead.
- Participate in Quality Assurance (QA) audits and the implementation of actions required to address deficiencies
- Participate in the MHRA Licensed inspections and closure of items on the resulting action plan.
- Participate in the Farwell Audits and closure of items on the resulting action plan.
- Undertake validation activities as required
- Develop own knowledge of GMP and QA and participate in staff training, development and accreditation.
- Identify cost pressures on QA services and advise on options for dealing with them.
- Maintain PQ folders
- To take part in completing and actioning CAPAs where needed.
- Review ongoing costs of the environmental monitoring and staff validation programmes and identify potential cost savings.
- Identify areas of development for the Quality Assurance service
- Source stability information for new products in line with Yellow Cover Document requirements, for review by the Quality Lead.
- Be familiar with and apply knowledge of COSHH and Health and Safety regulation.
- Promote and support the development and implementation of evidence-based practice for all staff.
- Develop and coordinate activities relating to Pharmacy key performance indicators including a program and schedule of audits to monitor performance and adherence to Policies and Procedures.
- Promote and maintain effective communication as well as disseminate information related to practice development.
- Check microbiological plates and provide advice with regards to the results.
- Follow Standard Operating Procedures and all relevant regulations in the course of duties.
- Inspect, assess and release products produced by the licensed manufacturing unit.
- Investigate any temperature monitoring deviations and trend analysis of medicines storage.
- Work independently within the constraints of your abilities
- Undertake quality assessments of products manufactured in-house and purchased for use in the Trust.
- Undertake risk assessments where required.
- Support the COSHH Specialist Adviser with COSHH assessments, training and administration.
- Work within Trust and local policies and procedures and to report any non-compliance to the Principal Technician Technical Services or Principal Pharmacist Cancer and Aseptic Services
- To be responsible for the day to day management of equipment and clean room device maintenance and testing. This will include:
- planned preventative maintenance,
- equipment calibration,
- troubleshooting and remedial action,
- maintaining an equipment & device fault register and prioritising workload,
- provision of reports and recommendations,
- liaison with external service contractors
- witnessing of validation, maintenance and testing.
- Maintain a clean and tidy environment and abide by the policies on security of drugs and premises and on the confidentiality of patients and staff.
- Meet the required commitment to personal CPD through continuing education and attendance at appropriate courses and study days.
- Maintain aseptic manipulation skills so as to be aware of issues, to understand the background and participate in the Aseptic rota.
- Set up validation processes for any new projects.
- Participate in the development, implementation and monitoring of aseptic pharmacy practice standards, guidelines, protocols, policies and QA SOPs.
- Provide input to ad hoc initiatives and projects as required.
- To undertake any training necessary for the safe and efficient performance of duties.
- To deliver training to other teams within aseptics where appropriate (e.g. GMP, COSHH)
- To participate in the supervision, training and mentoring of pharmacy support workers, pre-registration trainee pharmacy technicians, pre-registration pharmacists and trainees.
Supervises
Professional / Clinical responsibilities
- Maintain an active and compliant programme of CPD in accordance with hospital guidelines or relevant professional registration body.
- Work with relevant pharmacy staff in managing stock.
- Any other duties commensurate with the role or at the request of the Pharmacy Director and/or Pharmacy Operations Manager.
Education/Qualifications
- Pharmacy Technician registered with General Pharmaceutical Council (GPhC)
- Further training or qualifications in QA/QC
- Current certified GCP training
- Evidence of on-going professional development
- NVQ level 3/BTEC in Pharmaceutical Sciences or equivalent OR A level (or equivalent) science or maths qualification(s)
- GCSEs (or equivalent) in Maths and English
Competencies (Complexity of Work):
- Ability to produce clear, concise and well-articulated presentations
- Ability to undertake analysis of large or complex datasets
- Ability to critically analyse complex and difficult situations and apply problem-solving skills
- Critical thinking skills, decisive judgment and the ability to work with minimal supervision
- Ability to work in a pressurized environment and take appropriate action
- Experience analysing large or complex data sets and of using extraction tools
- Excellent analytical, verbal and written communication skills
- Reasonable understanding of Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP)
Person Specification
Qualifications
Essential
- BTEC/NVQ3 in Pharmaceutical Sciences or equivalent
- Accredited Checking Technician
- Short courses in management training
- Professional registration with the Royal Pharmaceutical Society of GB
- Evidence of CPD
Desirable
- HNC in Pharmaceutical Sciences
Experience
Essential
- Experience of day to day management of technical operations in a section of a hospital pharmacy
- Sufficient experience of hospital pharmacy to achieve the competencies required for the job
- Significant experience of the specialist service area of the post
- Supervision of a team of technicians/assistants
- Planning and implementing improvements in pharmacy service
- Writing and presenting reports
- Multidisciplinary working
- Problem solving involving most grades of hospital staff
- Involved in service development action plans
- Broad experience in communicating complex information to staff, patients, relatives and other healthcare professionals
- Equal opportunities
- Performance management, appraisals, objective setting
- Experience in pharmacy/ medicines legislation
- Experience in risk management and the investigation of incidents, errors and complaints drug withdrawals, hazard warnings etc
Desirable
- Disciplinary process
- Recruitment process
Skills
Essential
- Awareness of hospital pharmacy developments
- Extensive knowledge around the specialist service area of the post
- Competent in the skills required in the specialist service area of the post
- Accurate dispensing and checking skills
- Excellent numerical calculation skills
- Able to record and keep accurate records
- Able to accurately input data onto systems
- Competent in writing and implementing SOPs
- Good team leader/ manager skills
- Strong training skills
- Generally able to deal with difficult, concerned, angry, disturbed patients, relatives, carers
- Generally able to deal with difficult, angry, annoyed healthcare colleagues
- Must be able to concentrate for prolonged periods yet be able to deal with interruptions
- Able to plan, co-ordinate and balance conflicting priorities
- Able to demonstrate clear thinking and defend judgements
Desirable
- Understands JAC system and reports
- Awareness of benefits of IT
Personal Qualities
Essential
- Team player
- Enthusiastic, self-motivator and able to motivate others
- Technical credibility with colleagues
- Confident, but not over-confident
- Appropriately persistent
- Patient centred approach
- Approachable
- Aware of own limitations
- Innovative
- Appreciates feedback
- Ability to create a rapport
Other
Essential
- Some flexibility in working hours
- Keyboard skills and general IT knowledge
- Capable in Microsoft Outlook, Word
- Able to use a VDU
- Occasional moderate lifting
Desirable
- Capable in Excel, PowerPoint
- Driver, with use of motorised transport
Person Specification
Qualifications
Essential
- BTEC/NVQ3 in Pharmaceutical Sciences or equivalent
- Accredited Checking Technician
- Short courses in management training
- Professional registration with the Royal Pharmaceutical Society of GB
- Evidence of CPD
Desirable
- HNC in Pharmaceutical Sciences
Experience
Essential
- Experience of day to day management of technical operations in a section of a hospital pharmacy
- Sufficient experience of hospital pharmacy to achieve the competencies required for the job
- Significant experience of the specialist service area of the post
- Supervision of a team of technicians/assistants
- Planning and implementing improvements in pharmacy service
- Writing and presenting reports
- Multidisciplinary working
- Problem solving involving most grades of hospital staff
- Involved in service development action plans
- Broad experience in communicating complex information to staff, patients, relatives and other healthcare professionals
- Equal opportunities
- Performance management, appraisals, objective setting
- Experience in pharmacy/ medicines legislation
- Experience in risk management and the investigation of incidents, errors and complaints drug withdrawals, hazard warnings etc
Desirable
- Disciplinary process
- Recruitment process
Skills
Essential
- Awareness of hospital pharmacy developments
- Extensive knowledge around the specialist service area of the post
- Competent in the skills required in the specialist service area of the post
- Accurate dispensing and checking skills
- Excellent numerical calculation skills
- Able to record and keep accurate records
- Able to accurately input data onto systems
- Competent in writing and implementing SOPs
- Good team leader/ manager skills
- Strong training skills
- Generally able to deal with difficult, concerned, angry, disturbed patients, relatives, carers
- Generally able to deal with difficult, angry, annoyed healthcare colleagues
- Must be able to concentrate for prolonged periods yet be able to deal with interruptions
- Able to plan, co-ordinate and balance conflicting priorities
- Able to demonstrate clear thinking and defend judgements
Desirable
- Understands JAC system and reports
- Awareness of benefits of IT
Personal Qualities
Essential
- Team player
- Enthusiastic, self-motivator and able to motivate others
- Technical credibility with colleagues
- Confident, but not over-confident
- Appropriately persistent
- Patient centred approach
- Approachable
- Aware of own limitations
- Innovative
- Appreciates feedback
- Ability to create a rapport
Other
Essential
- Some flexibility in working hours
- Keyboard skills and general IT knowledge
- Capable in Microsoft Outlook, Word
- Able to use a VDU
- Occasional moderate lifting
Desirable
- Capable in Excel, PowerPoint
- Driver, with use of motorised transport
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
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).
