Job summary
We want you to join us as an integral part of Great Western Hospital's project to deliver our new Pharmacy Aseptic Services Unit (PASU) currently 4 months into construction with facility completion due June 2023. To be part of this project will give you a rare opportunity to be part of a service starting anew.
The facility will comprise of two clean rooms operating under Section 10 of the Medicines Act to locally provide high risk injectables to our patients including cytotoxic chemotherapy, monoclonal antibodies and CIVAs.
We are looking for a candidate with knowledge and experience in Quality Assurance who can primarily support in delivering our Pharmaceutical Quality Systems, facility and service validation and compliance to GMP.
You would also be supporting the wider pharmacy department for other regulated activities related to GxP such as Wholesale Dealing and clinical trials with the addition of leading on projects such as the delivery of an electronic Quality Management System.
Main duties of the job
To ensure that all Quality Assurance is effectively managed to meet agreed Trust and Pharmacy Department objectives whilst complying will all relevant national and local legislation, regulations and guidelines, particularly in relation to current Good Manufacturing Practice (cGMP), Good Distribution Practice (cGDP) Good Clinical Practice (cGCP).
Responsible for leading the implementing and maintaining a Pharmaceutical Quality Management System across all relevant areas of Pharmacy and monitor its effectiveness.
To provide expert quality assurance to the Pharmacy Aseptic Services Unit (PASU) in the quality review of their products and processes to maintain a high quality pharmaceutical aseptic service.
To provide expert quality assurance leadership to the Pharmacy Department in assuring the quality of the activities undertaken under its Wholesale Dealer Authorisation (WDA(H) license.
About us
Our Pharmacy team provides procurement, distribution, dispensary, ward-based clinical, cancer, aseptic and homecare services to Great Western Hospital and several other local community health services.
We embrace new technologies. Our pharmacy robots are invaluable members of our team; electronic prescribing is well-established in almost all inpatient and outpatient settings at Great Western Hospital; we use CareFlow EPR electronic patient records system and NerveCentre for electronic pharmacy handover notes; and all pharmacists are issued with their own laptop to capitalise on this connectivity.
We proudly uphold the Trust's STAR Values:
Service- We will put our patients first.
Teamwork- We will work together.
Ambition- We will aspire to provide the best service.
Respect- We will act with integrity.
and would expect successful candidates to also uphold these values.
Swindon has very good transport links. It is bordered by the Cotswolds to the North and West, the Upper Thames valley to the East, and the Marlborough Downs to the South, and the surrounding countryside is dotted with pretty villages and rural pubs. There are excellent local schools, sport and leisure facilities, a thriving local theatre and two large cinema complexes, with many more leisure activities available within an hour's travelling time in London, Reading, Oxford, Bath and Bristol.
Job description
Job responsibilities
Pharmaceutical Quality Management Systems
- Responsible for implementing the Pharmacys department Pharmaceutical Quality Systems (PQS), critically assessing with view to maintaining a continuous quality improvement cycle and in response to changes in regulations, legislation and audit recommendations.
- To keep abreast of all standards and guidelines relevant to the work of the Pharmacy department. To interpret the standards and guidelines and ensure that all protocols and SOPs meet with current requirements
- To maintain and promote continuous improvement of the PQS with effectiveness reviews of the following main activities:
- Investigations and Root Cause Analysis (RCA)
- Implementation of Corrective And Preventative Actions (CAPA)
- Recalls, complaints and deviation reporting
- Change controls
- Validations
- PQS trending and generation of key performance indicators
- To lead in the development and management of a robust electronic QMSwithin the Pharmacy department.
- Communicate highly complex technical information relating to the preparation and safety of medicines to healthcare professionals, where this information may be challenged.
- Overseeing delivery of QA and GxP training to pharmacy staff
Quality Exceptions
- To assist in the regular quality assurance review of all internal and external quality exceptions. This will involve investigation of product and process errors, defects, non-compliance and service user complaints.
- Work in co-operation with section managers to plan and implement corrective and preventative actions ;this may involve processes, procedure, training, policy, or service changes.
- To ensure section manager are undertaking timely management and close out of actions; and provide support where necessary.
- To undertake reviews to ensure that corrective and preventative actions are effective as part of Product Quality Reviews.
Pharmacy Aseptic Services Unit
- To provide expert quality assurance advice to the Pharmacy Aseptic Services Unit (PASU) senior staff by undertaking quality review of products and production processes to actively seek, identify and promote best practice and maintain a high quality pharmaceutical aseptic service.
- To liaise with the aseptic services senior staff to ensure adherence to current legislation and standards.
- To assist in the PASU self-inspection programme.
- To contribute to regular PASU quality meetings and escalate to and work with Aseptic Services Senior Leadership
- To ensure that appropriate risk management is undertaken within PASU including risk assessments.
- To support PASU in its development and on-going management of the environmental monitoring programme including microbiological, physical and temperature monitoring.
- To support PASU to set up and maintain electronic databases and paper-based record systems for environmental monitoring results within the department.
- To collaborate analysis, assess and interpret environmental monitoring results. To identify trends and in conjunction with the Deputy Aseptic Services Lead to devise action plans ensuring corrective and preventative action is taken.
- To develop, review and update Validation Master Plans and associated validation documents to ensure a robust validation program is followed.
- Where appropriate to contribute to User Requirement Specifications, Design Qualifications, Installation Qualifications, Operational Qualifications, Performance Qualifications and Validation Plans.
- Responsible for reviewing and advising on all aspects of validation related to process activity, operators, equipment and final products and making recommendations on improvement to validation plans.
- Ensure the preparation, approval, monitoring and review of specifications for starting materials, consumables, finished products and packaging materials are compliant with cGMP.
- Assist in the reviewing and assignment of stability to products prepared by PASU where necessary.
- To assist in the review of Service Level Agreements (SLAs) and Technical Quality Agreements (TAs) with suppliers.
Purchasing and Distribution
- To provide expert quality assurance advice to the Procurement and Distribution Lead and Responsible Person by undertaking quality review of WDA(H) processes to actively seek, identify and promote best practice in all aspects of Good Distribution Practice.
- To participate in routine meetings Procurement and Distribution Lead and Responsible Person to discuss present and future quality assurance issues
- To assist in the review of Service Level Agreements (SLAs) and Technical Agreements (TAs) with suppliers.
- To oversee the process of unlicensed medicines QC release with Pharmacy Medicines Effectiveness team and pharmacy stores department .
- To provide oversight on the assessment of the suitability of unlicensed medicines purchased by the Trust and release for use as appropriate (dependant on registration status).
- Support in the management of documentation and communication of Drug and Device Alerts to all the relevant areas of the Trust and assurance of related actions to mitigate risk i.e. quarantine.
Critical Equipment
- Assist in validation processes required for the installation and/or maintenance of critical equipment, including calibration, preparation and checking of documentation and supporting staff in performing necessary activities.
- Supporting the Pharmacy departments Planned Preventative Maintenance (PPM) schedule for critical equipment
- Responsible for overseeing management of temperature monitoring systems within the Pharmacy department, including regular maintenance/calibration and exception reports. To assist Section managers with investigation and CAPA in the event an excursion.
- To assist the Trust in Policy compliance regarding medicines storage.
- To provide expert QA advice to the Pharmacy Digital Team with the validation of any new computerised systems and assuring data integrity is maintained within GxP environments.
- Support in liaising with Trust Estates and Facilities Management providers regarding specialist facility and critical equipment matters
Audit
- To assist in external GxP audits (e.g. EL(97)52, WDA(H)), completing relevant documentation, and assuring required actions are planned and completed
- To support Pharmacy in the internal audit and process review of high-risk medicine areas such as outsourced radiopharmaceuticals, medical gases and controlled drugs.
Responsibilities for People and Training
- To maintain links with Regional QA Specialists including national and regional specialist groups
- Overseeing delivery of QA and GxP training to pharmacy staff
- To assist the relevant section leads in producing a range of training documents and resources to support the above training activities
- To be responsible for the line management including sickness absence, performance, annual appraisals, PDPs and role specific training.
- To be responsible for managing recruitment activities for pharmacy relevant to Quality Assurance
General
- To support the Pharmacy Department lead for Health and Safety , and raising areas of concern with relevant section managers and the Director of Pharmacy
- Is responsible for supporting management Pharmacys compliance with Control of Substances Hazardous to Health (COSHH) regulations.
- To support Senior Staff to improve standards and quality within the Pharmacy Department.
- To maintain sensitivity to the needs of patients, staff and other users of the service.
- To manage own workload effectively and efficiently ensuring that work is completed to agreed timescales.
- Keeping up to date with professional practice and undertaking CPD
- Contribute to the ongoing operational provision of the pharmacy service, as per department Rotas, to meet the needs of the service - evenings, weekends and bank holidays.
- Performing other duties as deemed necessary by the Director of Pharmacy
Budget Responsibilities
- Authorised signatory for HR issues, medicine orders and invoice payments.
Other Factors
- Other factors may include dealing with distressed patients/clients, regular VDU usage and the ability to concentrate on complex/demanding tasks
Job description
Job responsibilities
Pharmaceutical Quality Management Systems
- Responsible for implementing the Pharmacys department Pharmaceutical Quality Systems (PQS), critically assessing with view to maintaining a continuous quality improvement cycle and in response to changes in regulations, legislation and audit recommendations.
- To keep abreast of all standards and guidelines relevant to the work of the Pharmacy department. To interpret the standards and guidelines and ensure that all protocols and SOPs meet with current requirements
- To maintain and promote continuous improvement of the PQS with effectiveness reviews of the following main activities:
- Investigations and Root Cause Analysis (RCA)
- Implementation of Corrective And Preventative Actions (CAPA)
- Recalls, complaints and deviation reporting
- Change controls
- Validations
- PQS trending and generation of key performance indicators
- To lead in the development and management of a robust electronic QMSwithin the Pharmacy department.
- Communicate highly complex technical information relating to the preparation and safety of medicines to healthcare professionals, where this information may be challenged.
- Overseeing delivery of QA and GxP training to pharmacy staff
Quality Exceptions
- To assist in the regular quality assurance review of all internal and external quality exceptions. This will involve investigation of product and process errors, defects, non-compliance and service user complaints.
- Work in co-operation with section managers to plan and implement corrective and preventative actions ;this may involve processes, procedure, training, policy, or service changes.
- To ensure section manager are undertaking timely management and close out of actions; and provide support where necessary.
- To undertake reviews to ensure that corrective and preventative actions are effective as part of Product Quality Reviews.
Pharmacy Aseptic Services Unit
- To provide expert quality assurance advice to the Pharmacy Aseptic Services Unit (PASU) senior staff by undertaking quality review of products and production processes to actively seek, identify and promote best practice and maintain a high quality pharmaceutical aseptic service.
- To liaise with the aseptic services senior staff to ensure adherence to current legislation and standards.
- To assist in the PASU self-inspection programme.
- To contribute to regular PASU quality meetings and escalate to and work with Aseptic Services Senior Leadership
- To ensure that appropriate risk management is undertaken within PASU including risk assessments.
- To support PASU in its development and on-going management of the environmental monitoring programme including microbiological, physical and temperature monitoring.
- To support PASU to set up and maintain electronic databases and paper-based record systems for environmental monitoring results within the department.
- To collaborate analysis, assess and interpret environmental monitoring results. To identify trends and in conjunction with the Deputy Aseptic Services Lead to devise action plans ensuring corrective and preventative action is taken.
- To develop, review and update Validation Master Plans and associated validation documents to ensure a robust validation program is followed.
- Where appropriate to contribute to User Requirement Specifications, Design Qualifications, Installation Qualifications, Operational Qualifications, Performance Qualifications and Validation Plans.
- Responsible for reviewing and advising on all aspects of validation related to process activity, operators, equipment and final products and making recommendations on improvement to validation plans.
- Ensure the preparation, approval, monitoring and review of specifications for starting materials, consumables, finished products and packaging materials are compliant with cGMP.
- Assist in the reviewing and assignment of stability to products prepared by PASU where necessary.
- To assist in the review of Service Level Agreements (SLAs) and Technical Quality Agreements (TAs) with suppliers.
Purchasing and Distribution
- To provide expert quality assurance advice to the Procurement and Distribution Lead and Responsible Person by undertaking quality review of WDA(H) processes to actively seek, identify and promote best practice in all aspects of Good Distribution Practice.
- To participate in routine meetings Procurement and Distribution Lead and Responsible Person to discuss present and future quality assurance issues
- To assist in the review of Service Level Agreements (SLAs) and Technical Agreements (TAs) with suppliers.
- To oversee the process of unlicensed medicines QC release with Pharmacy Medicines Effectiveness team and pharmacy stores department .
- To provide oversight on the assessment of the suitability of unlicensed medicines purchased by the Trust and release for use as appropriate (dependant on registration status).
- Support in the management of documentation and communication of Drug and Device Alerts to all the relevant areas of the Trust and assurance of related actions to mitigate risk i.e. quarantine.
Critical Equipment
- Assist in validation processes required for the installation and/or maintenance of critical equipment, including calibration, preparation and checking of documentation and supporting staff in performing necessary activities.
- Supporting the Pharmacy departments Planned Preventative Maintenance (PPM) schedule for critical equipment
- Responsible for overseeing management of temperature monitoring systems within the Pharmacy department, including regular maintenance/calibration and exception reports. To assist Section managers with investigation and CAPA in the event an excursion.
- To assist the Trust in Policy compliance regarding medicines storage.
- To provide expert QA advice to the Pharmacy Digital Team with the validation of any new computerised systems and assuring data integrity is maintained within GxP environments.
- Support in liaising with Trust Estates and Facilities Management providers regarding specialist facility and critical equipment matters
Audit
- To assist in external GxP audits (e.g. EL(97)52, WDA(H)), completing relevant documentation, and assuring required actions are planned and completed
- To support Pharmacy in the internal audit and process review of high-risk medicine areas such as outsourced radiopharmaceuticals, medical gases and controlled drugs.
Responsibilities for People and Training
- To maintain links with Regional QA Specialists including national and regional specialist groups
- Overseeing delivery of QA and GxP training to pharmacy staff
- To assist the relevant section leads in producing a range of training documents and resources to support the above training activities
- To be responsible for the line management including sickness absence, performance, annual appraisals, PDPs and role specific training.
- To be responsible for managing recruitment activities for pharmacy relevant to Quality Assurance
General
- To support the Pharmacy Department lead for Health and Safety , and raising areas of concern with relevant section managers and the Director of Pharmacy
- Is responsible for supporting management Pharmacys compliance with Control of Substances Hazardous to Health (COSHH) regulations.
- To support Senior Staff to improve standards and quality within the Pharmacy Department.
- To maintain sensitivity to the needs of patients, staff and other users of the service.
- To manage own workload effectively and efficiently ensuring that work is completed to agreed timescales.
- Keeping up to date with professional practice and undertaking CPD
- Contribute to the ongoing operational provision of the pharmacy service, as per department Rotas, to meet the needs of the service - evenings, weekends and bank holidays.
- Performing other duties as deemed necessary by the Director of Pharmacy
Budget Responsibilities
- Authorised signatory for HR issues, medicine orders and invoice payments.
Other Factors
- Other factors may include dealing with distressed patients/clients, regular VDU usage and the ability to concentrate on complex/demanding tasks
Person Specification
Qualifications
Essential
- oRelevant Science Degree or oMaster's Degree in Pharmacy or oNVQ Level 3 in Pharmacy Services and BTEC in Pharmaceutical Science or oEquivalent qualification with substantial experience in the QA/QC field oRegistered or eligible to register with an appropriate professional body
Desirable
- oSpecialist higher Diploma in technical services (e.g. PTQA or Scientific Training Programme) or working towards. oQuality risk management training oChange management training
Experience
Essential
- oSignificant experience of working in a GxP environment oQuality control and quality assurance experience including environmental monitoring. oExperience of working within and maintaining a Pharmaceutical Quality Management System - Change Control, Deviation and Corrective and Preventive actions. oExperience of validation, qualification and re-commissioning oExperience of conducting quality-based investigations and root cause analysis oExperience in data interpretations and report writing oExperience of conducting internal GxP quality assurance audits oExperience of critically reviewing processes, recommending, and implementing changes as appropriate oExperience of project management of complex systems
Desirable
- oExperience of participation in external audit and hosting external auditors. oExperience of working within clinical trials oExperience of line managing personnel
Skills
Essential
- oGood organisational and time management skills. oAble to work independently and show initiative within limits of own authority whilst following agreed procedures oAbility to work under pressure, prioritising work as appropriate to achieve deadlines oStrong leadership and team working skills oProcedure and policy development oExcellent communication skills - verbal, written, electronic and interpersonal. oAble to give feedback constructively and deal with issues sensitively oSkill of managing personnel within teams oIn depth and practical knowledge of the legislation and standards relating to GxP, and ability to apply this knowledge to develop and maintain a Pharmaceutical Quality Management System. oKnowledge of clean room design and function and HTMs/HBNs oDemonstrated knowledge of principles and practices of aseptic preparation oKnowledge of pharmaceutical microbiology oPractical knowledge of the legislation and standards relating to GDP and its application to WDA (H) activities Knowledge of COSHH and health and safety at work oDemonstrable ability to identify problems, analyse complex root causes and propose practical and workable solutions for complex problems. oAnalytical and judgmental skills required to assess complex data and situations oDemonstrable ability to identify risk, carry out risk assessments, and manage action plans oHighly developed systems orientated approach oKnowledge and application of data integrity to GxP environments oUnderstanding of Product Quality Review requirements. o
Desirable
- oAn understanding of analytical chemistry/methods /instruments oUnderstanding of legal requirements, procedures, protocols governing clinical trials and GCP oGood understanding of the procedures, protocols and legal requirements governing the issue of non-licensed medicines oKnowledge of JAC computer system
Skills
Essential
- oSelf-motivated and driven to progress service provision, with ability to motivate team oAble to attend internal and external meetings, off site training days, required overtime related to managing service delivery etc. oAbility to work in an isolator fully gloved and gowned. oRegular VDU usage oWilling to work in other areas of the Trust or Trust-wide as and when required to do so.
Person Specification
Qualifications
Essential
- oRelevant Science Degree or oMaster's Degree in Pharmacy or oNVQ Level 3 in Pharmacy Services and BTEC in Pharmaceutical Science or oEquivalent qualification with substantial experience in the QA/QC field oRegistered or eligible to register with an appropriate professional body
Desirable
- oSpecialist higher Diploma in technical services (e.g. PTQA or Scientific Training Programme) or working towards. oQuality risk management training oChange management training
Experience
Essential
- oSignificant experience of working in a GxP environment oQuality control and quality assurance experience including environmental monitoring. oExperience of working within and maintaining a Pharmaceutical Quality Management System - Change Control, Deviation and Corrective and Preventive actions. oExperience of validation, qualification and re-commissioning oExperience of conducting quality-based investigations and root cause analysis oExperience in data interpretations and report writing oExperience of conducting internal GxP quality assurance audits oExperience of critically reviewing processes, recommending, and implementing changes as appropriate oExperience of project management of complex systems
Desirable
- oExperience of participation in external audit and hosting external auditors. oExperience of working within clinical trials oExperience of line managing personnel
Skills
Essential
- oGood organisational and time management skills. oAble to work independently and show initiative within limits of own authority whilst following agreed procedures oAbility to work under pressure, prioritising work as appropriate to achieve deadlines oStrong leadership and team working skills oProcedure and policy development oExcellent communication skills - verbal, written, electronic and interpersonal. oAble to give feedback constructively and deal with issues sensitively oSkill of managing personnel within teams oIn depth and practical knowledge of the legislation and standards relating to GxP, and ability to apply this knowledge to develop and maintain a Pharmaceutical Quality Management System. oKnowledge of clean room design and function and HTMs/HBNs oDemonstrated knowledge of principles and practices of aseptic preparation oKnowledge of pharmaceutical microbiology oPractical knowledge of the legislation and standards relating to GDP and its application to WDA (H) activities Knowledge of COSHH and health and safety at work oDemonstrable ability to identify problems, analyse complex root causes and propose practical and workable solutions for complex problems. oAnalytical and judgmental skills required to assess complex data and situations oDemonstrable ability to identify risk, carry out risk assessments, and manage action plans oHighly developed systems orientated approach oKnowledge and application of data integrity to GxP environments oUnderstanding of Product Quality Review requirements. o
Desirable
- oAn understanding of analytical chemistry/methods /instruments oUnderstanding of legal requirements, procedures, protocols governing clinical trials and GCP oGood understanding of the procedures, protocols and legal requirements governing the issue of non-licensed medicines oKnowledge of JAC computer system
Skills
Essential
- oSelf-motivated and driven to progress service provision, with ability to motivate team oAble to attend internal and external meetings, off site training days, required overtime related to managing service delivery etc. oAbility to work in an isolator fully gloved and gowned. oRegular VDU usage oWilling to work in other areas of the Trust or Trust-wide as and when required to do so.
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).
