Job summary We are looking for a Scientist or Pharmacy Technician with experience of working in a pharmaceutical manufacturing environment, particularly in a quality related role. As well as the standard NHS benefits, this is a fantastic opportunity to work alongside like-minded professionals in a dynamic, collaborative, and supportive environment with a varied portfolio of work to support patient care at LTHT. This post holder will be able to both showcase and develop their quality management expertise. This is an exciting time to join us as we are part of a national programme to transform aseptic services in England, with West Yorkshire Association of Acute Trusts (WYAAT) identified as one of Englands pathfinder sites. Our team is expanding to support the build of a new Aseptic Hub to manufacture medicines for the WYAAT collaborative, with hospitals in the region working together for the best possible patient care. As well as performing QC checks on pharmaceutical batches for the aseptic preparation unit and dispensary support unit, you will also be involved in the management of the quality system and implementing exciting new projects throughout the manufacturing facility. If you are passionate about making a difference this will be a great opportunity to be part of the building the future of a highly valued service. Main duties of the job This 1-year fixed term role will focus on: i) QC checking of pharmaceutical batches manufactured under our Specials licence. ii) Final accuracy checking in our Section 10 Pharmacy Aseptic Units. iii) Supporting the management and maintenance of the Quality Management System. iv) Supporting change management throughout the department. v) Co-ordination, organisation and implementation of departmental schedules and action plans. vi) Training of other team members, students, and the wider Pharmacy Department. The post is full-time, working 37.5 hours per week Monday-Friday. There will also be some Bank Holiday and weekend commitments (13 days per year). The department aims to support flexible working arrangements, and we have car parking on site. About us Leeds Teaching Hospitals is one of the largest and busiest NHS Trusts in the country, offering a range of both general and specialist hospital services with excellent clinical outcomes for patients. The Pharmacy Department at LTHT is highly respected, forward thinking and recognised within the organisation for collaborative working. We offer excellent career progression whilst working in a friendly and supportive team. The QA/QC team has been instrumental in supporting the LTHT Pharmacy Manufacturing Unit in developing an industry leading service, producing ready to administer injectable medicines. We are proud to say that we have created a positive working environment with a hardworking and dedicated workforce who feel valued and share a team goal to put the patients first. Leeds Teaching Hospitals is committed to our process of redeploying 'at risk' members of our existing workforce to new roles. As such, all our job adverts are subject to this policy and we reserve the right to close, delay or remove adverts while this process is completed. If you do experience a delay in the shortlisting stage of the recruitment cycle, please bear with us while this process is completed, and contact the named contact if you have any questions. Date posted 28 February 2025 Pay scheme Agenda for change Band Band 6 Salary £37,338 to £44,962 a year Contract Fixed term Duration 12 months Working pattern Full-time, Flexible working Reference number C9298-MMP-355 Job locations St. James's University Hospital Beckett Street Leeds LS9 7TF Job description Job responsibilities Ensures aseptic preparation is carried out efficiently and responsively and in compliance with current legislation and standards and the principles of Good Manufacturing Practice. Ensures equipment and facilities are subject to an appropriate programme of validation Ensures (in liaison with service managers) that the following are undertaken. - Physical and Environmental Monitoring - Operator and Process Validation - Audit (and subsequent action planning) Leads a small team of technical and support staff, as required, in the Quality Assurance Service ensuring they have appropriate induction, regular appraisals, personal development plans and challenging but realistic objectives. Conducts sickness and disciplinary reviews as required. Ensure Trust Absence Management policy is adhered to and that staff absence is reported and return to work interviews conducted in a timely manner. Responsible for limited recruitment and selection of technical and support staff within the service Ensures regular team briefings and meetings are held and that there is good communication for all staff using a variety of means, written and verbal. Provides operational support to the service, including sessional supervision and accuracy checking /- final product approval. This will usually be on a planned basis. Maintains high professional standards at all times and ensure compliance with statutory regulations concerning pharmaceuticals and the provision of Health and Safety at work are complied with Promotes the cost-effective use of equipment and supplies and to ensure that appropriate ordering and costing procedures are in place. Participates in regular internal audits of the service and take action to remedy and deficiencies to continually improve the quality of the service. Works with key stakeholders in ensuring the delivery of training and competency assessments for staff working within the preparative service, including supporting the assessment of NVQ candidates. Contributes to pharmacy service developments and ensure that change is managed smoothly in relation to area of responsibility. Leads the implementation of new changes, based on best evidence or expert scientific opinion. Identifies and implements risk reduction strategies in preparative service areas, in support of the Preparative Services Leadership Team. Develops efficient communication channels with the rest of pharmacy and key customers to ensure a good understanding of the service and the roles and responsibilities of staff Manages difficult problems including providing advice on production, COSHH issues and issues relating to safe use of unlicensed medicines. In some situations information may be ambiguous or limited and opinions may differ on preferred outcomes Quality assessment of unlicensed medicines Critical review of stability studies and related product literature Professional Release of Licensed Batch Manufacture - This activity involves being responsible for the quality and safety of released batches of intravenous preparations manufactured in the Aseptic Production Unit under the terms of the MHRA (Medicines & Healthcare Regulatory Agency) Specials Licence. It also involves being responsible for the quality and safety of individual released batches of oral and topical preparations manufactured in the Dispensary Support Unit under the terms of the MHRA Specials Licence. Products prepared in this unit are supplied to LTHT and other users within the local Health economy including Local Care Direct and local health Trusts. Supports the QA/QC management team in ensuring that all licensed medicine preparation within the Trust is carried out accordance with cGMP. Final Accuracy Checking /- final product approval in the unlicensed aseptic dispensaries Assists in Health and Safety Management Participates in research and development activities within speciality including formulation and product development. Plans and performs GMP and GDP audits in MHRA licensed facilities and all other Preparative Services areas. Plans and performs Governance Audits in Preparative Services dispensing areas. Provides scientific support and advice to the MMPS Leadership team on a range of issues, including those outside the Preparative Service. Supervises, teaches, and assesses junior pharmacy staff completing training modules within preparative services Job description Job responsibilities Ensures aseptic preparation is carried out efficiently and responsively and in compliance with current legislation and standards and the principles of Good Manufacturing Practice. Ensures equipment and facilities are subject to an appropriate programme of validation Ensures (in liaison with service managers) that the following are undertaken. - Physical and Environmental Monitoring - Operator and Process Validation - Audit (and subsequent action planning) Leads a small team of technical and support staff, as required, in the Quality Assurance Service ensuring they have appropriate induction, regular appraisals, personal development plans and challenging but realistic objectives. Conducts sickness and disciplinary reviews as required. Ensure Trust Absence Management policy is adhered to and that staff absence is reported and return to work interviews conducted in a timely manner. Responsible for limited recruitment and selection of technical and support staff within the service Ensures regular team briefings and meetings are held and that there is good communication for all staff using a variety of means, written and verbal. Provides operational support to the service, including sessional supervision and accuracy checking /- final product approval. This will usually be on a planned basis. Maintains high professional standards at all times and ensure compliance with statutory regulations concerning pharmaceuticals and the provision of Health and Safety at work are complied with Promotes the cost-effective use of equipment and supplies and to ensure that appropriate ordering and costing procedures are in place. Participates in regular internal audits of the service and take action to remedy and deficiencies to continually improve the quality of the service. Works with key stakeholders in ensuring the delivery of training and competency assessments for staff working within the preparative service, including supporting the assessment of NVQ candidates. Contributes to pharmacy service developments and ensure that change is managed smoothly in relation to area of responsibility. Leads the implementation of new changes, based on best evidence or expert scientific opinion. Identifies and implements risk reduction strategies in preparative service areas, in support of the Preparative Services Leadership Team. Develops efficient communication channels with the rest of pharmacy and key customers to ensure a good understanding of the service and the roles and responsibilities of staff Manages difficult problems including providing advice on production, COSHH issues and issues relating to safe use of unlicensed medicines. In some situations information may be ambiguous or limited and opinions may differ on preferred outcomes Quality assessment of unlicensed medicines Critical review of stability studies and related product literature Professional Release of Licensed Batch Manufacture - This activity involves being responsible for the quality and safety of released batches of intravenous preparations manufactured in the Aseptic Production Unit under the terms of the MHRA (Medicines & Healthcare Regulatory Agency) Specials Licence. It also involves being responsible for the quality and safety of individual released batches of oral and topical preparations manufactured in the Dispensary Support Unit under the terms of the MHRA Specials Licence. Products prepared in this unit are supplied to LTHT and other users within the local Health economy including Local Care Direct and local health Trusts. Supports the QA/QC management team in ensuring that all licensed medicine preparation within the Trust is carried out accordance with cGMP. Final Accuracy Checking /- final product approval in the unlicensed aseptic dispensaries Assists in Health and Safety Management Participates in research and development activities within speciality including formulation and product development. Plans and performs GMP and GDP audits in MHRA licensed facilities and all other Preparative Services areas. Plans and performs Governance Audits in Preparative Services dispensing areas. Provides scientific support and advice to the MMPS Leadership team on a range of issues, including those outside the Preparative Service. Supervises, teaches, and assesses junior pharmacy staff completing training modules within preparative services Person Specification Skills and Behaviours Essential Able to cope with a large and varied workload Able to work accurately and under pressure Qualifications Essential Honours degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Biomedical Sciences (or similar) OR BTEC in pharmaceutical science or NVQ level 3 in pharmacy services Eligible for registration with the Health and Care Professions Council (HCPC), General Pharmaceutical Council (GPhC), Royal Society of Chemistry (RSC), Institute of Biology or equivalent body Desirable Further education in Pharmacy Technical Services e.g. PTQA or STP Experience Essential Experience of aseptic preparation Accuracy checking training Good dispensing, distribution, manufacturing practice Incident and error reporting Desirable Managing change Risk assessments Person Specification Skills and Behaviours Essential Able to cope with a large and varied workload Able to work accurately and under pressure Qualifications Essential Honours degree in Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Biomedical Sciences (or similar) OR BTEC in pharmaceutical science or NVQ level 3 in pharmacy services Eligible for registration with the Health and Care Professions Council (HCPC), General Pharmaceutical Council (GPhC), Royal Society of Chemistry (RSC), Institute of Biology or equivalent body Desirable Further education in Pharmacy Technical Services e.g. PTQA or STP Experience Essential Experience of aseptic preparation Accuracy checking training Good dispensing, distribution, manufacturing practice Incident and error reporting Desirable Managing change Risk assessments 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. Certificate of Sponsorship 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. Certificate of Sponsorship 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). Employer details Employer name Leeds Teaching Hospitals Address St. James's University Hospital Beckett Street Leeds LS9 7TF Employer's website https://www.leedsth.nhs.uk/ (Opens in a new tab)