Job summary
An exciting opportunity has arisen to lead the Quality Assurance team for the Aseptics Units.
We are seeking an experienced professional with expertise in delivering quality assurance excellence across the Unlicensed Units at Guy's and St Thomas' Trust. This role will provide key quality assurance guidance to the units and oversee the delivery of QA services.
The individual must have experience in completion of of quality assurance documentation and be an enthusiastic individual who can engage and deliver to multiple teams. Also have technical knowledge of Good Manufacturing Practices; must have dealt with inspections and experience of remediation and/or regulatory compliance issues.
Main duties of the job
This is an exciting post and will include the following duties amongst others:
- To support the development of the strategic direction, leadership and the advancement of Pharmaceutical QA Services to the Trust and to external customers of the Trust, to meet local, regional and nationally agreed requirements and priorities focusing on aseptic product portfolio
- To critically evaluate, and where required escalate, the Pharmaceutical Quality Systems across all areas to ensure that compliance with regulatory requirements is maintained and performance is reviewed as per departmental procedures.
- To be responsible for QA advice and support necessary for the management of Clinical Trials in the Pharmacy in accordance with the statutory requirements for Good Clinical Practice
- To take a lead role in validating the Trust's pharmaceutical production facilities to ensure compliance with required national standards
This role will see you form working relationships across several departments within Pharmacy, senior Trust managers and regional quality assurance colleagues.
About us
The Pharmacy Technical Services department is one of several departments within Pharmacy. The Quality Assurance department is located at Guy's hospital however, the deputy Quality Assurance manager will be expected to work across all sites to deliver the Quality Assurance service.
The post holder will work closely with a number of different GMP and Quality teams based at the trust.
Job description
Job responsibilities
Professional Leadership
- To support and assist the Head of Pharmaceutical Quality in the efficient and effective running of the Quality Assurance function.
- To demonstrate expert technical knowledge and advanced level of clinical technical reasoning and judgement.
- To be recognized as a national expert within Quality Assurance
Policy and Planning - To develop Pharmaceutical Quality Systems to meet the changing needs and demands of the Trust and of external Regulators (eg: MHRA and Regional Quality Assurance)
- To contribute to the planning and design of new and upgraded pharmaceutical manufacturing, preparation and dispensing facilities within the Trust
- To develop, write and present business cases for equipment, staff resources and service developments within the Pharmaceutical QA Services function
- To advise the Head of Pharmaceutical Quality and Senior Pharmacy staff in the determination of policy and plans for pharmaceutical services
- To lead on the risk assessment and documentation of major changes to be made to Pharmacy Technical Services.
Personnel Management, Training and Development - To manage QA staff, including objective setting, appraisals, performance and attendance monitoring
- To be responsible for recruitment of staff to QA and QC Services, including advertising, short-listing, interviewing and selecting staff
- To develop training programmes for QA staff to ensure GMP and GLP compliance of Quality Services
- To undertake and manage Trust HR procedures in respect of discipline, grievances and sickness absence
- To participate in the training of pharmacists, scientists, pre-registration pharmacy graduates, technicians, and student pharmacy technicians as required
Resource Management - To support the purchase of new and replacement equipment. To help define the specifications, sourcing, price negotiation, installation, maintenance and repair of such equipment
- To be responsible for the purchase of consumables for Quality Assurance.
Research and Development - To undertake, supervise and give guidance on research projects arising from the work of technical services.
- To publish research and development work
- To participate in investigations into the formulae used in the Production Unit, and into the determination of stability and shelf life
- To undertake and support the development, formulation and validation of new products in response to clinical need and risk management in accordance with objectives set by the Head of Pharmaceutical Quality.
- To be responsible for QA advice and support necessary for the management of Clinical Trials in the Pharmacy in accordance with the statutory requirements for Good Clinical Practice
Quality Assurance - To establish, monitor and review QA Standard Operating Procedures
- To monitor, review and approve, specifications for starting materials, finished products, packaging materials which have been prepared by the Quality Control Department
- To monitor, review and approve manufacturing documents and Standard Operating Procedures which have been prepared by the Production Units
- To manage the provision of a quality assurance service to various GSTT units and external bodies.
- To monitor, review and approve analytical methods for carrying out tests and analyses, both physico-chemical and microbiological
- To develop and manage Technical Agreements for the provision of services to GSTT by external companies
- To act as lead Releasing Officer for components, starting materials and finished products used by or prepared with the Trust
- To examine components, starting materials and finished products for compliance with specifications and to release or reject each batch as appropriate
- To manage and coordinate the response to the remote temperature monitoring system across the Pharmacy department
- To generate Certificates of Analysis on request to support the supply of manufactured medicines to external customers of the Trust
Pharmaceutical Quality System Management
- To critically evaluate the Pharmaceutical Quality Systems across all areas to ensure that compliance with regulatory requirements is maintained.
- Through local huddles and other meetings work with the Accountable Pharmacists to review Pharmaceutical Quality System metrics and escalate deficiencies in resources and other key issues to the Head of Pharmaceutical Quality and Associate and Chief Pharmacists
- Working with the Accountable Pharmacists monitor capacity within all Pharmacy Technical Services areas to maintain the Pharmaceutical Quality System and report Pharmaceutical Quality System performance at management review meetings
- To develop and maintain an effective Deviation Reporting system within Pharmacy Technical Services. To be responsible for ensuring that Deviations are fully investigated as to Root Causes and to approve proposed corrective and preventive actions
- To develop and maintain a document control system as part of the Pharmaceutical Quality System, in line with GMP and MHRA requirements
- To provide documented evidence/reports to demonstrate that the Pharmaceutical Quality System is performing to the required standards
Audit
- To oversee the internal audit programme for the aseptic units and ensure this is maintained and appropriate to the level of risk of each unit
- To undertake internal audits and document and review internal audit reports as directed by the Head of Pharmaceutical Quality
- To provide Internal Audit reports to Senior Management on a regular basis
- To provide regulatory audit progress reports to the MHRA, Regional QA and Senior Management as required
- To represent Quality Assurance at regulatory audits and meet the requirements of the auditor in a clear and concise manner.
- To lead on the response to audit deficiencies and ensure these are carried out in a timely manner
Facilities Monitoring
- To ensure monitoring takes place in accordance with GMP
- To provide training to all staff in the techniques used to monitor the manufacturing environment.
- To manage the recording, documentation and review of environmental monitoring results
- To manage the Deviation reporting system for environmental monitoring and implement corrective/preventative actions in a timely manner
- To manage the maintenance of results databases, review and provide reports on trended data on a regular basis
- To develop, maintain and review external contracts with companies providing a pharmaceutical microbiological testing service.
Product Safety - To investigate and report on medicine defects, arising from both commercial and GSTT-made products, liaising with the Region and Regulatory Authorities as appropriate
- To co-ordinate actions within the Trust on drug recalls
- To provide the QA advisory role in the Trusts purchase of medicines
- To advise the Trust on the use of unlicensed medicines
- To assess the quality of unlicensed medicines supplied from outside the Trust and provide recommendations as to their suitability for use within the Trust
Validation - To provide specialist knowledge and advice to senior technical staff on validation requirements for new equipment, facilities and processes
- To manage the commissioning and validation of new pharmaceutical Manufacturing/QC built within the Trust
- To approve Technical Agreements made with external contractors for the (re)validation of equipment, facilities and processes
- To review periodic equipment, facility and process (re)validations to ensure compliance with Technical Agreements in place and the appropriateness of results. To manage any Deviations thrown up by the (re)validations
- To liaise with the Lifecycle Manager to ensure the key objectives within the validation master plan for Technical Services are met.
Regional Liaison - To participate in regional training initiatives for manufacturing, preparation, dispensing and quality assurance
- To deputise as a member of the Regional Quality Assurance Group
- To be a member of other regional groups as required by the Regional Quality Assurance Pharmacist, Head of Pharmaceutical Quality or Chief Pharmacist
- To undertake the collection and collation of information relating to Quality Assurance by arrangement with the Regional Quality Assurance Pharmacist
Other Duties - To undertake other reasonable duties as requested by the Head of Pharmaceutical Quality, Chief Pharmacist or the Regional Quality Assurance Pharmacist
- To at all times practise in accordance with the Code of Ethics of the General Pharmaceutical Council, whether registered with the GPhC or not
- To take personal responsibility for promoting a safe environment and safe patient care by identifying areas of risk and following the Patient Safety Incident Reporting Framework policy and procedure.
Job description
Job responsibilities
Professional Leadership
- To support and assist the Head of Pharmaceutical Quality in the efficient and effective running of the Quality Assurance function.
- To demonstrate expert technical knowledge and advanced level of clinical technical reasoning and judgement.
- To be recognized as a national expert within Quality Assurance
Policy and Planning - To develop Pharmaceutical Quality Systems to meet the changing needs and demands of the Trust and of external Regulators (eg: MHRA and Regional Quality Assurance)
- To contribute to the planning and design of new and upgraded pharmaceutical manufacturing, preparation and dispensing facilities within the Trust
- To develop, write and present business cases for equipment, staff resources and service developments within the Pharmaceutical QA Services function
- To advise the Head of Pharmaceutical Quality and Senior Pharmacy staff in the determination of policy and plans for pharmaceutical services
- To lead on the risk assessment and documentation of major changes to be made to Pharmacy Technical Services.
Personnel Management, Training and Development - To manage QA staff, including objective setting, appraisals, performance and attendance monitoring
- To be responsible for recruitment of staff to QA and QC Services, including advertising, short-listing, interviewing and selecting staff
- To develop training programmes for QA staff to ensure GMP and GLP compliance of Quality Services
- To undertake and manage Trust HR procedures in respect of discipline, grievances and sickness absence
- To participate in the training of pharmacists, scientists, pre-registration pharmacy graduates, technicians, and student pharmacy technicians as required
Resource Management - To support the purchase of new and replacement equipment. To help define the specifications, sourcing, price negotiation, installation, maintenance and repair of such equipment
- To be responsible for the purchase of consumables for Quality Assurance.
Research and Development - To undertake, supervise and give guidance on research projects arising from the work of technical services.
- To publish research and development work
- To participate in investigations into the formulae used in the Production Unit, and into the determination of stability and shelf life
- To undertake and support the development, formulation and validation of new products in response to clinical need and risk management in accordance with objectives set by the Head of Pharmaceutical Quality.
- To be responsible for QA advice and support necessary for the management of Clinical Trials in the Pharmacy in accordance with the statutory requirements for Good Clinical Practice
Quality Assurance - To establish, monitor and review QA Standard Operating Procedures
- To monitor, review and approve, specifications for starting materials, finished products, packaging materials which have been prepared by the Quality Control Department
- To monitor, review and approve manufacturing documents and Standard Operating Procedures which have been prepared by the Production Units
- To manage the provision of a quality assurance service to various GSTT units and external bodies.
- To monitor, review and approve analytical methods for carrying out tests and analyses, both physico-chemical and microbiological
- To develop and manage Technical Agreements for the provision of services to GSTT by external companies
- To act as lead Releasing Officer for components, starting materials and finished products used by or prepared with the Trust
- To examine components, starting materials and finished products for compliance with specifications and to release or reject each batch as appropriate
- To manage and coordinate the response to the remote temperature monitoring system across the Pharmacy department
- To generate Certificates of Analysis on request to support the supply of manufactured medicines to external customers of the Trust
Pharmaceutical Quality System Management
- To critically evaluate the Pharmaceutical Quality Systems across all areas to ensure that compliance with regulatory requirements is maintained.
- Through local huddles and other meetings work with the Accountable Pharmacists to review Pharmaceutical Quality System metrics and escalate deficiencies in resources and other key issues to the Head of Pharmaceutical Quality and Associate and Chief Pharmacists
- Working with the Accountable Pharmacists monitor capacity within all Pharmacy Technical Services areas to maintain the Pharmaceutical Quality System and report Pharmaceutical Quality System performance at management review meetings
- To develop and maintain an effective Deviation Reporting system within Pharmacy Technical Services. To be responsible for ensuring that Deviations are fully investigated as to Root Causes and to approve proposed corrective and preventive actions
- To develop and maintain a document control system as part of the Pharmaceutical Quality System, in line with GMP and MHRA requirements
- To provide documented evidence/reports to demonstrate that the Pharmaceutical Quality System is performing to the required standards
Audit
- To oversee the internal audit programme for the aseptic units and ensure this is maintained and appropriate to the level of risk of each unit
- To undertake internal audits and document and review internal audit reports as directed by the Head of Pharmaceutical Quality
- To provide Internal Audit reports to Senior Management on a regular basis
- To provide regulatory audit progress reports to the MHRA, Regional QA and Senior Management as required
- To represent Quality Assurance at regulatory audits and meet the requirements of the auditor in a clear and concise manner.
- To lead on the response to audit deficiencies and ensure these are carried out in a timely manner
Facilities Monitoring
- To ensure monitoring takes place in accordance with GMP
- To provide training to all staff in the techniques used to monitor the manufacturing environment.
- To manage the recording, documentation and review of environmental monitoring results
- To manage the Deviation reporting system for environmental monitoring and implement corrective/preventative actions in a timely manner
- To manage the maintenance of results databases, review and provide reports on trended data on a regular basis
- To develop, maintain and review external contracts with companies providing a pharmaceutical microbiological testing service.
Product Safety - To investigate and report on medicine defects, arising from both commercial and GSTT-made products, liaising with the Region and Regulatory Authorities as appropriate
- To co-ordinate actions within the Trust on drug recalls
- To provide the QA advisory role in the Trusts purchase of medicines
- To advise the Trust on the use of unlicensed medicines
- To assess the quality of unlicensed medicines supplied from outside the Trust and provide recommendations as to their suitability for use within the Trust
Validation - To provide specialist knowledge and advice to senior technical staff on validation requirements for new equipment, facilities and processes
- To manage the commissioning and validation of new pharmaceutical Manufacturing/QC built within the Trust
- To approve Technical Agreements made with external contractors for the (re)validation of equipment, facilities and processes
- To review periodic equipment, facility and process (re)validations to ensure compliance with Technical Agreements in place and the appropriateness of results. To manage any Deviations thrown up by the (re)validations
- To liaise with the Lifecycle Manager to ensure the key objectives within the validation master plan for Technical Services are met.
Regional Liaison - To participate in regional training initiatives for manufacturing, preparation, dispensing and quality assurance
- To deputise as a member of the Regional Quality Assurance Group
- To be a member of other regional groups as required by the Regional Quality Assurance Pharmacist, Head of Pharmaceutical Quality or Chief Pharmacist
- To undertake the collection and collation of information relating to Quality Assurance by arrangement with the Regional Quality Assurance Pharmacist
Other Duties - To undertake other reasonable duties as requested by the Head of Pharmaceutical Quality, Chief Pharmacist or the Regional Quality Assurance Pharmacist
- To at all times practise in accordance with the Code of Ethics of the General Pharmaceutical Council, whether registered with the GPhC or not
- To take personal responsibility for promoting a safe environment and safe patient care by identifying areas of risk and following the Patient Safety Incident Reporting Framework policy and procedure.
Person Specification
Skills
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
Experience
Essential
- Previous assessable experience of effectively managing or leading in a Pharmaceutical Manufacturing facility
- Experience of managing change and deviations within a pharmaceutical quality management system
- Demonstrated knowledge of the validation requirements for pharmaceutical facilities, equipment and products
- Experience of evaluating the effectiveness of a Pharmaceutical quality management system and management review
- Experience of managing change and deviations within a pharmaceutical quality management system
Knowledge/Qualifications
Essential
- Pharmacy degree or Master's degree in science-based discipline
- Post-graduate qualification relevant to pharmaceutical manufacturing or portfolio that demonstrates the acquisition and use of an equivalent level of specialist pharmaceutical knowledge
- Demonstrated ability to undertake the day to day management, motivation and appraisal of staff
- Demonstrated ability to evaluate and improve service quality
Desirable
Person Specification
Skills
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
Experience
Essential
- Previous assessable experience of effectively managing or leading in a Pharmaceutical Manufacturing facility
- Experience of managing change and deviations within a pharmaceutical quality management system
- Demonstrated knowledge of the validation requirements for pharmaceutical facilities, equipment and products
- Experience of evaluating the effectiveness of a Pharmaceutical quality management system and management review
- Experience of managing change and deviations within a pharmaceutical quality management system
Knowledge/Qualifications
Essential
- Pharmacy degree or Master's degree in science-based discipline
- Post-graduate qualification relevant to pharmaceutical manufacturing or portfolio that demonstrates the acquisition and use of an equivalent level of specialist pharmaceutical knowledge
- Demonstrated ability to undertake the day to day management, motivation and appraisal of staff
- Demonstrated ability to evaluate and improve service quality
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).
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).
