Job Description

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 be an integral member of the teams responsible for ensuring the successful validation and start up of these new facilities and its safe and effective operation.



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.

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 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.