Job summary
The Pharmacy department of the Royal Free London NHS Trust is a friendly, progressive and expanding unit dedicated to providing the highest standards of pharmaceutical care and service in this large, internationally renowned teaching hospital. The Trust has good transport links to the West End and major mainline train stations such as Kings Cross, Euston, Stratford, London Bridge and Charing Cross.
The Royal Free London NHST Trust includes the Barnet and Chase Farm hospital sites making us one of the largest NHS Trusts in the UK. In addition to this, we have an expanding and high profile clinical trials unit which forms part of the Institute of Immunity and Transplantation based on the Hampstead arm of the Trust.
Main duties of the job
We are seeking an experienced QA/QC manager to maintain and develop the QA/QC service provided to the MHRA licensed unit at the Royal Free Hampstead site and also the Section 10 unit at Barnet Hospital.
The facility at RFH has a MHRA Manufacturer "Specials" Licence (MS), a Wholesale Distribution Authorisation (WDA(H)) and a Manufacturer Licence for Investigational Medicinal Products (Clinical Trials) (MIA(IMP)).
After a number of facility upgrades over the last few years, the Royal Free Hospital unit is currently undergoing an Autoclave replacement programme to improve capacity, capability and preparing for the future requirements of the NHS. The post holder will be required to understand the technology and ensure the service fully realises the benefit the equipment provides.
The post holder will also a key enabler to developing the Clinical Trial services provided by the Pharmacy and R&D Departments in line with the Trust strategy.
The ideal candidate will have a Degree in Pharmacy, Chemistry, or an equivalent scientific qualification, a working knowledge of GMP/GLP/GCP and significant experience in pharmaceutical quality assurance. They should have a confident, proactive attitude to the tasks required and the ability to forge relationships with a wide range of staff both within and beyond the Pharmacy Services unit within the Trust.
About us
Our trust has around 10,000 staff serving 1.6 million patients. It comprises Barnet, Chase Farm and Royal Free Hospitals and more than 30 services in the community. Our mission is to deliver world class care and expertise in our clinical services, underpinned by world class teaching and research and we continue to measure our progress against our five governing objectives: excellent outcomes, excellent patient and staff experience, excellent value for taxpayers' money, being safe and meeting our external duties, and building a strong organisation.
The Trust takes pride as one of the major specialist centres for infectious diseases, liver and renal transplants, breast and plastic surgery, myeloma, and neuroendocrine tumours. Working in one of the main speciality centres brings exciting opportunities to see a range of patients at different levels of complexities. Everyone is welcome at Royal Free London NHS Foundation Trust. We're proud of our diversity and we continue to undertake new initiatives to advance equality for LGBT+, BME, gender equality, staff carers and people with disabilities and lived experiences to promote good relations and understanding between our staff.
The Pharmacy department is a friendly, progressive, and expanding unit dedicated to providing the highest standards of pharmaceutical care and service in this internationally renowned teaching hospital. Quality improvement and cost-effective, safe use of medicines is at the forefront of everything we do.
Job description
Job responsibilities
- To identify and develop a strategic direction for the provision of Pharmaceutical QA/QC Services
- To advise the Chief Pharmacist on policy in relation to QA/QC Services
- To join the Chief Pharmacist and the Senior Pharmacy Leadership Team in the determination of policy and plans for the Trust Pharmaceutical Services.
- To contribute to the planning and design of all pharmaceutical services including but not limited to manufacturing, preparation, clinical trial and dispensing.
- To advise on the purchase of medicines, including unlicensed products, for use within the Trust.
- To be responsible for, monitor and review QA/QC procedures.
- To approve, monitor, review and update specifications for raw materials, finished products, packaging materials and labels.
- To monitor, review and approve manufacturing documents and procedures.
- To establish sampling procedures and to select or secure samples in accordance with specifications and to release or reject products/batches as appropriate.
- To maintain records of the analysis of products manufactured within the Trust.
- To establish and implement procedures for environmental monitoring in the Pharmacy Production and preparation areas and to maintain records of the monitoring completed.
- To evaluate medication storage conditions and advise on requirements across the Trust.
- To advise the Trust Health and Safety Committee on pharmaceutical matters and to co-ordinates Health and Safety activities for the Pharmacy Department.
- To advise the Pharmacy Department and other Trust Departments on COSHH requirements.
- To advise the Trust Medical Gas Committee and provide the Trust Medical Gas Testing service across the sites.
- To act as the Quality Controller for piped medical gases adhering to the requirements of HTM02.
- To liaise with the Medicines and Healthcare Products Regulatory Agency (MHRA) for all licensed Pharmacy activities.
- To liaise with the Regional Quality Assurance Unit on all aspects of Section 10 activity across the Trust sites and be responsible for ensuring the unit(s) are compliant and inspection ready.
- To liaise with the MHRA on all aspects of licensed activity across the Trust sites and be responsible for ensuring the unit(s) are compliant and inspection ready.
- To maintain contact with the MHRA, along with the Principal Pharmacist Production Services, on potential changes to the Pharmacy Manufacturing Unit and involve the inspectorate at an early stage in the design process.
- To manage, in conjunction with the Principal Pharmacist Production Services, the documentation relating to the Manufacturers Specials (MS) and MIA(IMP) licences as a QA.
- To ensure that the QA/QC services are integrated into the Trust Clinical Governance agenda with a view to reducing risk in the preparation and clinical use of medicines within the Trust.
- To be responsible, along with the Principal Pharmacist Production Services, for qualification, commissioning and validation of new facilities and equipment.
- To be responsible for the approval of standard operation procedures within the Pharmacy Production and QA/QC units.
- To contribute to the formulation of patient specific medicines in response to the individuals clinical needs.
- To act as a Releasing Officer for products manufactured in the Pharmacy Manufacturing units.
- To be a named Qualified Person (QP) on the MHRA MIA(IMP) licence.
- To be the person named as being responsible for Quality Control on the MS licence.
- To undertake internal GMP audits within the Trust licensed facilities.
- To undertake GMP audits of external suppliers as required.
- To be responsible for maintaining the Quality Management System used by all Trust manufacturing facilities. This involves being responsible for the effective management of non-compliance reviews, implementation and management of agreed action plans, advice and technical input into investigations and quality risk management issues.
- To be responsible for the effective management of the Change Control and Deficiency programme ensuring improvements and any regulatory changes are assessed and implemented.
- To be responsible, with the Principal Pharmacist Production Services, for the development and management of a robust document control system as an integrated part of the Quality system according to MHRA and Regional QA requirements.
- To provide specialist knowledge and advice to other senior technical staff, including those outside of Pharmacy, on validation requirements for all new equipment, facilities and processes.
- To manage the validation of new equipment and facilities within the Pharmacy Departments including selection of contractor, resource and project management.
- To review the pharmaceutical related validation processes on a regular basis ensuring compliance with external requirements.
- To investigate and report on defective medicines discovered in the Trust.
- To act as the Pharmacy contact for the national and regional alerting systems and co-ordinate action on medication alerts within the Trust.
- To maintain the QA/QC budget within the available resources.
- To contribute to the Trust savings plan e.g. FIP programme.
- To maintain the QA/QC Laboratory to fulfil its role and advise the Chief Pharmacist of any changes to requirements.
- To manage the planning of QA/QC equipment procurement and ensure that all equipment is maintained and its performance verified and documented.
- The postholder will support the Chief Pharmacist in promoting the Trust and the Pharmacy Departments Research and Development programmes.
- To undertake, supervise and give guidance on the preparation of pharmaceutical clinical trial materials used within the Trust.
- To participate in investigations into the formulae used in the Pharmacy Production unit into stability and shelf life of the products produced.
- To ensure that all IMPs are prepared according to GMP and to be a named QP for Pharmacy.
- To contribute to the preparation and publication of reports when required
PROFESSIONAL RESPONSIBILITIES
- To remain on the General Pharmaceutical Council (GPhC) register.
- To undertake GCP and GMP training as required.
- To maintain 100% MAST record.
- To act as a role model to all other Pharmacy staff.
- To be a member of the Regional Quality Assurance Working Group.
- To participate in Regional training initiatives for manufacturing, preparation, dispensing and QA.
- To always behave in a manner that is professional, positive and polite.
- To be accountable for own professional actions.
- To be responsible for ensuring that (s)he remains aware of current developments in pharmacy, human resources and employment law
- To be responsible for his/her own professional development and participate in own Performance and Development planning.
- To complete CPD.
To ensure that the QA/QC Laboratory meets the requirements of Good Laboratory Practice (GLP) at all times.
- To ensure that the QA/QC Laboratory participates in a recognized accreditation scheme.
- To advise Trust Heads of Departments on risk assessment processes.
- To manage staff assigned to the QA/QC Department including objective setting, appraisals, performance monitoring and attendance monitoring.
- To develop and implement systems to monitor performance of line managers to ensure that all staff within QA/QC are managed effectively, are well motivated and contribute to the work of the whole Pharmacy Department.
- Undertake formal Trust Workforce procedures e.g. disciplinary, grievance and sickness absence investigations both within and external to the Pharmacy Department.
- To be responsible for the recruitment of staff within QA/QC including the preparation of paperwork and advertisements, short listing and participating in interview panels.
- To be responsible for ensuring that a GMP compliant competency based training system is developed, implemented and maintained for all QA/QC staff.
- To ensure that all QA/QC staff undertake CPD
- To participate in the training of Trust staff in QA/QC and Medical Gas requirements.
- To manage annual, study, unpaid and special leave requests for QA/QC staff.
See Job description for further details and the general teams and conditions.
Job description
Job responsibilities
- To identify and develop a strategic direction for the provision of Pharmaceutical QA/QC Services
- To advise the Chief Pharmacist on policy in relation to QA/QC Services
- To join the Chief Pharmacist and the Senior Pharmacy Leadership Team in the determination of policy and plans for the Trust Pharmaceutical Services.
- To contribute to the planning and design of all pharmaceutical services including but not limited to manufacturing, preparation, clinical trial and dispensing.
- To advise on the purchase of medicines, including unlicensed products, for use within the Trust.
- To be responsible for, monitor and review QA/QC procedures.
- To approve, monitor, review and update specifications for raw materials, finished products, packaging materials and labels.
- To monitor, review and approve manufacturing documents and procedures.
- To establish sampling procedures and to select or secure samples in accordance with specifications and to release or reject products/batches as appropriate.
- To maintain records of the analysis of products manufactured within the Trust.
- To establish and implement procedures for environmental monitoring in the Pharmacy Production and preparation areas and to maintain records of the monitoring completed.
- To evaluate medication storage conditions and advise on requirements across the Trust.
- To advise the Trust Health and Safety Committee on pharmaceutical matters and to co-ordinates Health and Safety activities for the Pharmacy Department.
- To advise the Pharmacy Department and other Trust Departments on COSHH requirements.
- To advise the Trust Medical Gas Committee and provide the Trust Medical Gas Testing service across the sites.
- To act as the Quality Controller for piped medical gases adhering to the requirements of HTM02.
- To liaise with the Medicines and Healthcare Products Regulatory Agency (MHRA) for all licensed Pharmacy activities.
- To liaise with the Regional Quality Assurance Unit on all aspects of Section 10 activity across the Trust sites and be responsible for ensuring the unit(s) are compliant and inspection ready.
- To liaise with the MHRA on all aspects of licensed activity across the Trust sites and be responsible for ensuring the unit(s) are compliant and inspection ready.
- To maintain contact with the MHRA, along with the Principal Pharmacist Production Services, on potential changes to the Pharmacy Manufacturing Unit and involve the inspectorate at an early stage in the design process.
- To manage, in conjunction with the Principal Pharmacist Production Services, the documentation relating to the Manufacturers Specials (MS) and MIA(IMP) licences as a QA.
- To ensure that the QA/QC services are integrated into the Trust Clinical Governance agenda with a view to reducing risk in the preparation and clinical use of medicines within the Trust.
- To be responsible, along with the Principal Pharmacist Production Services, for qualification, commissioning and validation of new facilities and equipment.
- To be responsible for the approval of standard operation procedures within the Pharmacy Production and QA/QC units.
- To contribute to the formulation of patient specific medicines in response to the individuals clinical needs.
- To act as a Releasing Officer for products manufactured in the Pharmacy Manufacturing units.
- To be a named Qualified Person (QP) on the MHRA MIA(IMP) licence.
- To be the person named as being responsible for Quality Control on the MS licence.
- To undertake internal GMP audits within the Trust licensed facilities.
- To undertake GMP audits of external suppliers as required.
- To be responsible for maintaining the Quality Management System used by all Trust manufacturing facilities. This involves being responsible for the effective management of non-compliance reviews, implementation and management of agreed action plans, advice and technical input into investigations and quality risk management issues.
- To be responsible for the effective management of the Change Control and Deficiency programme ensuring improvements and any regulatory changes are assessed and implemented.
- To be responsible, with the Principal Pharmacist Production Services, for the development and management of a robust document control system as an integrated part of the Quality system according to MHRA and Regional QA requirements.
- To provide specialist knowledge and advice to other senior technical staff, including those outside of Pharmacy, on validation requirements for all new equipment, facilities and processes.
- To manage the validation of new equipment and facilities within the Pharmacy Departments including selection of contractor, resource and project management.
- To review the pharmaceutical related validation processes on a regular basis ensuring compliance with external requirements.
- To investigate and report on defective medicines discovered in the Trust.
- To act as the Pharmacy contact for the national and regional alerting systems and co-ordinate action on medication alerts within the Trust.
- To maintain the QA/QC budget within the available resources.
- To contribute to the Trust savings plan e.g. FIP programme.
- To maintain the QA/QC Laboratory to fulfil its role and advise the Chief Pharmacist of any changes to requirements.
- To manage the planning of QA/QC equipment procurement and ensure that all equipment is maintained and its performance verified and documented.
- The postholder will support the Chief Pharmacist in promoting the Trust and the Pharmacy Departments Research and Development programmes.
- To undertake, supervise and give guidance on the preparation of pharmaceutical clinical trial materials used within the Trust.
- To participate in investigations into the formulae used in the Pharmacy Production unit into stability and shelf life of the products produced.
- To ensure that all IMPs are prepared according to GMP and to be a named QP for Pharmacy.
- To contribute to the preparation and publication of reports when required
PROFESSIONAL RESPONSIBILITIES
- To remain on the General Pharmaceutical Council (GPhC) register.
- To undertake GCP and GMP training as required.
- To maintain 100% MAST record.
- To act as a role model to all other Pharmacy staff.
- To be a member of the Regional Quality Assurance Working Group.
- To participate in Regional training initiatives for manufacturing, preparation, dispensing and QA.
- To always behave in a manner that is professional, positive and polite.
- To be accountable for own professional actions.
- To be responsible for ensuring that (s)he remains aware of current developments in pharmacy, human resources and employment law
- To be responsible for his/her own professional development and participate in own Performance and Development planning.
- To complete CPD.
To ensure that the QA/QC Laboratory meets the requirements of Good Laboratory Practice (GLP) at all times.
- To ensure that the QA/QC Laboratory participates in a recognized accreditation scheme.
- To advise Trust Heads of Departments on risk assessment processes.
- To manage staff assigned to the QA/QC Department including objective setting, appraisals, performance monitoring and attendance monitoring.
- To develop and implement systems to monitor performance of line managers to ensure that all staff within QA/QC are managed effectively, are well motivated and contribute to the work of the whole Pharmacy Department.
- Undertake formal Trust Workforce procedures e.g. disciplinary, grievance and sickness absence investigations both within and external to the Pharmacy Department.
- To be responsible for the recruitment of staff within QA/QC including the preparation of paperwork and advertisements, short listing and participating in interview panels.
- To be responsible for ensuring that a GMP compliant competency based training system is developed, implemented and maintained for all QA/QC staff.
- To ensure that all QA/QC staff undertake CPD
- To participate in the training of Trust staff in QA/QC and Medical Gas requirements.
- To manage annual, study, unpaid and special leave requests for QA/QC staff.
See Job description for further details and the general teams and conditions.
Person Specification
Royal Free World Class Values
Essential
- Demonstrable ability to meet the Trust Values
Education & professional Qualifications
Essential
- Pharmacist or relevant Science degree
- Full membership of a relevant Professional Body
Desirable
- Registered as a "Qualified Person" for IMP's
- Further qualification in relevant technical or management area
- European Computer Driving Licence
Experience
Essential
- Proven experience of good performance in previous jobs
- Extensive experience in pharmaceutical manufacturing, including experience in a large licensed facility
- Experience in a QC Laboratory and a QA Department
- Experience of managing & motivating staff
- Experience of training and supervising staff
- Experience of a managing and developing a Quality Service
- Demonstrated experience & ability to successfully supervise and undertake a range of technical projects
- Demonstrated expert technical knowledge covering Pharmaceutical QA and Production
- Knowledge of all aspects of GMP, and all current legislation and regulations and ability to apply this knowledge to develop and run Quality Services
- Demonstrated knowledge of principals and practices of aseptics/parenterals e.g. formulation, stability, administration, legal issues
- Knowledge of COSHH and health and safety at work
- An awareness of current national standards, guidelines and service delivery issues relevant to Technical Services and ability to apply these to Quality Services
- Demonstrated knowledge of formulation and stability
- Demonstrated knowledge of GMP/GLP/ Quality Systems
- Demonstrated knowledge of Validation and Audit
- Demonstrated knowledge of Chemistry and Analytical Techniques
- Demonstrated knowledge of Pharmaceutical microbiology
- Demonstrated knowledge of Medical Piped Gas Testing
Person Specification
Royal Free World Class Values
Essential
- Demonstrable ability to meet the Trust Values
Education & professional Qualifications
Essential
- Pharmacist or relevant Science degree
- Full membership of a relevant Professional Body
Desirable
- Registered as a "Qualified Person" for IMP's
- Further qualification in relevant technical or management area
- European Computer Driving Licence
Experience
Essential
- Proven experience of good performance in previous jobs
- Extensive experience in pharmaceutical manufacturing, including experience in a large licensed facility
- Experience in a QC Laboratory and a QA Department
- Experience of managing & motivating staff
- Experience of training and supervising staff
- Experience of a managing and developing a Quality Service
- Demonstrated experience & ability to successfully supervise and undertake a range of technical projects
- Demonstrated expert technical knowledge covering Pharmaceutical QA and Production
- Knowledge of all aspects of GMP, and all current legislation and regulations and ability to apply this knowledge to develop and run Quality Services
- Demonstrated knowledge of principals and practices of aseptics/parenterals e.g. formulation, stability, administration, legal issues
- Knowledge of COSHH and health and safety at work
- An awareness of current national standards, guidelines and service delivery issues relevant to Technical Services and ability to apply these to Quality Services
- Demonstrated knowledge of formulation and stability
- Demonstrated knowledge of GMP/GLP/ Quality Systems
- Demonstrated knowledge of Validation and Audit
- Demonstrated knowledge of Chemistry and Analytical Techniques
- Demonstrated knowledge of Pharmaceutical microbiology
- Demonstrated knowledge of Medical Piped Gas Testing
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).
