Job summary
Here at the University Hospitals Dorset , we are looking for a highly diligent conscientious professional to work as Quality Assurance Lead in the Aseptic Preparation Unit in Poole Hospital.
This is an exciting innovative role for a registered pharmacy professional to be imbedded within our UHD technical services team to assist the Accountable Pharmacists in managing the pharmacy QA & QC for the Cancer Services within UHD which is produced in the unlicensed aseptic preparation unit APU in Poole Hospital. Within our team we value all our team members and their development.
We are looking for a highly skilled pharmacy professional with significant experience and background of working in quality assurance from working in aseptic services or a manufacturing GMP environment.
The post holder will work alongside a team of pharmacy professionals to meet the quality and compliance demands of this diverse service. The role will provide QA & QC support and advice, conduct audits and drive quality improvements and be able to work as a product approver to release products prepared in APU.
The post holder will be a member of the Senior Aseptic Management Team and will have direct responsibility for managing the supporting QA technician.
The post is full time. Expected weekend shifts of 1 in 5 Sunday, and approximately one Bank Holiday shift per year.
Base Location: University Hospital Dorset - Poole hospital site
Interview Date: TBC
Main duties of the job
The Quality Assurance Lead will play a key role in the quality control, and safe dispensing of cytotoxic and immunotherapy agents prepared in the Aseptic Unit in Poole.
This role requires extensive QA & QC knowledge in Aseptic preparation of injectable cytotoxic and immunotherapy agents . Adherence to regulatory standards, and a commitment to ensuring the safety and efficacy of aseptic products. The QA lead will lead QA & QC operations in the Aseptic Preparation Unit, support the development and implementation of QMS, and provide mentorship to junior staff.
This person will be responsible for the effective management and submission of the required information and data according to iQAAPS (Quality Assurance of Aseptic Preparation Services) with includes performing internal audits and participating in external audits by regional QA and writing action plans and completing these actions in a timely manner.
The post holder will be responsible for managing the human resources of the QA team within aseptic services.
About us
Our values define who we are as #TeamUHD. They underpin everything we do now and in the future. They define how we treat our patients, visitors, and each other, our valued teammates and colleagues. UHD are investing in services across the Trust, with many being transformed and developed following merger and the New Hospital Programme. This means that some services may move site this year or next, either temporarily or long term. Recruiting Managers interviewing for this role will be happy to answer any specific questions that you have about this at interview.
Please note if the role or service is relocated as part of a planned move, employees will not be eligible for excess mileage reimbursement. Travel from the potholder's home to the new work base will be considered a normal commute. Any other changes not related to this relocation will be managed according to the relevant Trust or National terms and conditions.
Job description
Job responsibilities
For further details see main job description and personal specification for the role as Quality Assurance Lead.
Job description
Job responsibilities
For further details see main job description and personal specification for the role as Quality Assurance Lead.
Person Specification
Qualifications
Essential
- Master's degree in pharmacy or BTEC Applied Science & NVQ3 Pharmacy Services or equivalent
- Registered with the GPHC
- Accredited Product Approver & Accredited Pre and In Process Checker
- Management qualification or equivalent experience
- Good Clinical Practice for clinical trials.
- Pharmaceutical Technology and Quality Assurance (PTQA)
- NVQ assessor to TAQA standard or equivalent
Desirable
- Specialised knowledge of H&S, risk assessment and management, IOSHH managing safely or equivalent
- Member of Association of Pharmacy Technicians UK/ BOPA
Experience
Essential
- Significant and broad experience of working in NHS Technical Services section 10 or manufacturing units with considerable experience of QA required
- Demonstrated ability to undertake staff training, day to day management, motivation and appraisals and performance reviews of technical staff, managing staff sickness and disciplinary issues
- Previous experience as a lead technician within technical services and the release of medicinal products in a section 10 unit, with final decision making on fitness of the product for patient use.
- Experience of management and investigations of Quality Exceptions
- Experience in undertaking risk assessments
- Experience in taking part in an iQAAPS (Quality Assurance of Aseptic Preparation Services) audit and writing action plans.
- Experience in submitting KPI data on Quiqsolutions
Desirable
- Experience of service development
- Recruitment and selection
- Knowledge of electronic prescribing systems e.g. Mosaiq, and other hospital pharmacy computer systems e.g. WellSky, LERNS,EPR, Q-Pulse, IQAAPS
- Teaching / coaching experience
Technical Skills Competencies
Essential
- Ability to work under own initiative without close supervision
- Advanced oral and written communication skills - the ability to communicate confidently and effectively at different levels with various users of the service, including patients who may have language difficulties.
- Ability to communicate effectively in difficult/demanding circumstances.
- Ability to work under pressure, remains calm. Ability to work at speed accurately and concentrate for prolonged periods of time whilst able to deal with interruptions while maintaining accuracy.
- Ability to organise and prioritise work with regards to time management skills and the ability to meet deadlines
- Ability to analyse information and make judgements. Ability to use the technical knowledge, reasoning and professional judgement to critically review and assess highly complex data and information relating to facilities and products in order to evaluate their suitability for the intended use.
- Good presentation skills & project planning and implementation
- Information technology skills including Microsoft Word, Excel, Powerpoint
- Familiar with use of QPulse
Desirable
- QPulse Superuser or equivalent technical competency
- Knowledge of standard chemotherapy regimens
- Understanding of actions and uses of chemotherapy, and cancer in general
Knowledge
Essential
- Good clinical knowledge of current therapeutics and pharmacy practice
- In depth knowledge of current legislation and guidelines relating to pharmaceuticals QA and GMP, GCP and Quality Systems
- Knowledge of validation requirements for pharmaceutical facilities, equipment and processes
Desirable
- Knowledge of Codes of Practice / Customer Care / NHS plan for Pharmacy
- Knowledge of wider NHS agenda and issues General Pharmaceutical Council professional
Person Specification
Qualifications
Essential
- Master's degree in pharmacy or BTEC Applied Science & NVQ3 Pharmacy Services or equivalent
- Registered with the GPHC
- Accredited Product Approver & Accredited Pre and In Process Checker
- Management qualification or equivalent experience
- Good Clinical Practice for clinical trials.
- Pharmaceutical Technology and Quality Assurance (PTQA)
- NVQ assessor to TAQA standard or equivalent
Desirable
- Specialised knowledge of H&S, risk assessment and management, IOSHH managing safely or equivalent
- Member of Association of Pharmacy Technicians UK/ BOPA
Experience
Essential
- Significant and broad experience of working in NHS Technical Services section 10 or manufacturing units with considerable experience of QA required
- Demonstrated ability to undertake staff training, day to day management, motivation and appraisals and performance reviews of technical staff, managing staff sickness and disciplinary issues
- Previous experience as a lead technician within technical services and the release of medicinal products in a section 10 unit, with final decision making on fitness of the product for patient use.
- Experience of management and investigations of Quality Exceptions
- Experience in undertaking risk assessments
- Experience in taking part in an iQAAPS (Quality Assurance of Aseptic Preparation Services) audit and writing action plans.
- Experience in submitting KPI data on Quiqsolutions
Desirable
- Experience of service development
- Recruitment and selection
- Knowledge of electronic prescribing systems e.g. Mosaiq, and other hospital pharmacy computer systems e.g. WellSky, LERNS,EPR, Q-Pulse, IQAAPS
- Teaching / coaching experience
Technical Skills Competencies
Essential
- Ability to work under own initiative without close supervision
- Advanced oral and written communication skills - the ability to communicate confidently and effectively at different levels with various users of the service, including patients who may have language difficulties.
- Ability to communicate effectively in difficult/demanding circumstances.
- Ability to work under pressure, remains calm. Ability to work at speed accurately and concentrate for prolonged periods of time whilst able to deal with interruptions while maintaining accuracy.
- Ability to organise and prioritise work with regards to time management skills and the ability to meet deadlines
- Ability to analyse information and make judgements. Ability to use the technical knowledge, reasoning and professional judgement to critically review and assess highly complex data and information relating to facilities and products in order to evaluate their suitability for the intended use.
- Good presentation skills & project planning and implementation
- Information technology skills including Microsoft Word, Excel, Powerpoint
- Familiar with use of QPulse
Desirable
- QPulse Superuser or equivalent technical competency
- Knowledge of standard chemotherapy regimens
- Understanding of actions and uses of chemotherapy, and cancer in general
Knowledge
Essential
- Good clinical knowledge of current therapeutics and pharmacy practice
- In depth knowledge of current legislation and guidelines relating to pharmaceuticals QA and GMP, GCP and Quality Systems
- Knowledge of validation requirements for pharmaceutical facilities, equipment and processes
Desirable
- Knowledge of Codes of Practice / Customer Care / NHS plan for Pharmacy
- Knowledge of wider NHS agenda and issues General Pharmaceutical Council professional
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).
