Job summary
We are looking for an enthusiastic, self-motivated and responsible quality professional to develop their career in the evolving landscape of Quality Assurance and Aseptic Preparation, working closely with a variety of teams within Pharmacy.
Previous experience working in the quality assurance field is essential for this role and you will have ideally undertaken quality roles within aseptic services
The successful candidate will be working in the new St Thomas' Cancer & ATMP Aseptic Units and will bean integral member of the teams responsible for ensuring the successful validation and start up of these new facilities and its safe and effective operation.
Main duties of the job
- To support the QA team in the delivery of QA services, meeting the needs of the pharmacy department and all associated technical units.
- To provide specialist quality advice to a range of technical and clinical areas within the Trust.
- To support the use of our pharmaceutical quality system tool and to assess SOPs, deviations, risk assessments, change controls and laboratory and microbiological out of specification results.
- To assist with internal auditing and inspection readiness activities.
About us
Guy's and St Thomas' Pharmacy Technical Services is one of the largest NHS pharmacy technical departments in the country and employs over 120 staff across multiple manufacturing and preparation areas. Our large on-site QA team provides support and guidance to all units providing technical services working under our MS, MIA(IMP) and WDA licences, as well as to units providing unlicensed 'Section 10' preparation services. This role is specific to the Section 10 preparation services within the Trust.
Job description
Job responsibilities
Job Summary
The job holder will play a key role in quality assurance of the all medicines manufacturing and preparation activities ensuring a safe, efficient and compliant service.
Duties and Responsibilities
Quality Assurance
- To be part of the Quality Assurance (QA) team and carry out defined QA responsibilities as defined by the QA rotas.
- To support the QA team in the delivery of the QA service, meeting the needs of the pharmacy department according to legal requirements and licenses held by the Trust
- Provide support in the use of our quality management system tool, and assess and act on Deviations, Risk Assessments, CAPA, Change Controls and Temporary Changes. To monitor performance against agreed metrics and escalate non-compliance to senior managers.
- To critically assess deviations, risk assessments, change controls and CAPAs raised by production areas and provide QA sign off. To approve SOPs for use in production areas.
- Review out of specification physical and microbiological monitoring results and make decisions on suitability of the environment to be used and its impact on product quality.
- Support the unit teams to become Inspection Ready, particularly in the area of updating of key documents [e.g. SOPs, Specifications, Test Methods].
- As part of regulatory inspection readiness to ensure document availability and gather documented evidence to confirm resolution of deficiencies identified in our quality system.
- To assist QA Specialists with auditing activities.
- To lead on drug defect investigations and drug recalls within the Trust, including complaints.
- To investigate patient complaints of Trust manufactured products.
- To undertake validation reviews.
- To write departmental procedures in line with current guidelines.
- To carry out log meetings, quality review meetings and monthly trending meetings with production areas as required.
- To utilise the deviation reporting system and change control system and to trend the data.
- To be trained to use computerised facility monitoring systems and documentation systems. To act at all times in compliance with data integrity requirements.
- To act as a releasing officer for all medicinal products manufactured within the Trust and for NHS units with which the Trust has contracts.
- To provide QA support to procurement and governance teams in the assessment and approval of new unlicensed medicines to be bought into the Trust. To act as releasing officer for ULMs received into the Trust.
- To respond to queries appropriately.
Development
19. To investigate and implement the use of an electronic systems including archiving, quality management and manufacturing.
20. To undertake continuous professional development.
21. Assist the QA team in the development of the QA service.
22. To keep abreast of the latest QA guidelines, and ensure that all activities undertaken within the units meet current legislation such as GMP/GDP/GLP, COSHH etc.
Training
23. Assist in the training programme for QA personnel and other pharmacy personnel as required.
Other
24. To undertake other duties as required by the Deputy QA Manager and/or Head of Quality, including project work.
25. To deputise for QA Specialists where required to supervise QA support staff.
Please see attached Person Specification for further information.
Job description
Job responsibilities
Job Summary
The job holder will play a key role in quality assurance of the all medicines manufacturing and preparation activities ensuring a safe, efficient and compliant service.
Duties and Responsibilities
Quality Assurance
- To be part of the Quality Assurance (QA) team and carry out defined QA responsibilities as defined by the QA rotas.
- To support the QA team in the delivery of the QA service, meeting the needs of the pharmacy department according to legal requirements and licenses held by the Trust
- Provide support in the use of our quality management system tool, and assess and act on Deviations, Risk Assessments, CAPA, Change Controls and Temporary Changes. To monitor performance against agreed metrics and escalate non-compliance to senior managers.
- To critically assess deviations, risk assessments, change controls and CAPAs raised by production areas and provide QA sign off. To approve SOPs for use in production areas.
- Review out of specification physical and microbiological monitoring results and make decisions on suitability of the environment to be used and its impact on product quality.
- Support the unit teams to become Inspection Ready, particularly in the area of updating of key documents [e.g. SOPs, Specifications, Test Methods].
- As part of regulatory inspection readiness to ensure document availability and gather documented evidence to confirm resolution of deficiencies identified in our quality system.
- To assist QA Specialists with auditing activities.
- To lead on drug defect investigations and drug recalls within the Trust, including complaints.
- To investigate patient complaints of Trust manufactured products.
- To undertake validation reviews.
- To write departmental procedures in line with current guidelines.
- To carry out log meetings, quality review meetings and monthly trending meetings with production areas as required.
- To utilise the deviation reporting system and change control system and to trend the data.
- To be trained to use computerised facility monitoring systems and documentation systems. To act at all times in compliance with data integrity requirements.
- To act as a releasing officer for all medicinal products manufactured within the Trust and for NHS units with which the Trust has contracts.
- To provide QA support to procurement and governance teams in the assessment and approval of new unlicensed medicines to be bought into the Trust. To act as releasing officer for ULMs received into the Trust.
- To respond to queries appropriately.
Development
19. To investigate and implement the use of an electronic systems including archiving, quality management and manufacturing.
20. To undertake continuous professional development.
21. Assist the QA team in the development of the QA service.
22. To keep abreast of the latest QA guidelines, and ensure that all activities undertaken within the units meet current legislation such as GMP/GDP/GLP, COSHH etc.
Training
23. Assist in the training programme for QA personnel and other pharmacy personnel as required.
Other
24. To undertake other duties as required by the Deputy QA Manager and/or Head of Quality, including project work.
25. To deputise for QA Specialists where required to supervise QA support staff.
Please see attached Person Specification for further information.
Person Specification
Knowledge/Qualifications
Essential
- Undergraduate or postgraduate Masters degree in a Science related discipline
- Post graduate technical services qualification
- Equivalent demonstrated portfolio of experience and short courses
Experience
Essential
- Previous QA experience in a pharmaceutical setting.
- Experience of quality systems and document management systems.
- Previous experience of the investigation, risk and impact assessment of deviations
- Previous experience of GMP change management
Desirable
- Experience of aseptic preparation of CIVAS, Chemotherapy, TPN
- Previous evaluated experience working as a releasing officer in a licenced pharmaceutical production unit with a comprehensive portfolio of products.
- Experience of being audited by external bodies e.g. MHRA GMP inspections, Regional Quality EL audits.
Skills
Essential
- Demonstrated practical knowledge of GDP, GMP and QA.
- Able to produce reports, spreadsheets and presentations using Microsoft packages.
- Ability to direct and organise own time and time of others
- Demonstrated ability to identify training needs of self and others
- Ability to identify and solve problems
Desirable
- Demonstrated ability to identify and manage risks.
- Ability to review and perform QA sign on documents written by others.
- Demonstrated ability to undertake the day to day management, motivation and appraisal of staff.
- Demonstrated ability to apply the principles of GCP and GMP to the running of clinical trials
- Familiarity and demonstrated competence with use of computerised software systems for GMP activities and monitoring.
Person Specification
Knowledge/Qualifications
Essential
- Undergraduate or postgraduate Masters degree in a Science related discipline
- Post graduate technical services qualification
- Equivalent demonstrated portfolio of experience and short courses
Experience
Essential
- Previous QA experience in a pharmaceutical setting.
- Experience of quality systems and document management systems.
- Previous experience of the investigation, risk and impact assessment of deviations
- Previous experience of GMP change management
Desirable
- Experience of aseptic preparation of CIVAS, Chemotherapy, TPN
- Previous evaluated experience working as a releasing officer in a licenced pharmaceutical production unit with a comprehensive portfolio of products.
- Experience of being audited by external bodies e.g. MHRA GMP inspections, Regional Quality EL audits.
Skills
Essential
- Demonstrated practical knowledge of GDP, GMP and QA.
- Able to produce reports, spreadsheets and presentations using Microsoft packages.
- Ability to direct and organise own time and time of others
- Demonstrated ability to identify training needs of self and others
- Ability to identify and solve problems
Desirable
- Demonstrated ability to identify and manage risks.
- Ability to review and perform QA sign on documents written by others.
- Demonstrated ability to undertake the day to day management, motivation and appraisal of staff.
- Demonstrated ability to apply the principles of GCP and GMP to the running of clinical trials
- Familiarity and demonstrated competence with use of computerised software systems for GMP activities and monitoring.
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).
