- Postholder will provide senior strategic leadership on all aspects of quality assurance in relation to pharmaceutical manufacturing and preparation in UHS aseptic and radiopharmaceutical services.
- To lead with respect to all quality and regulatory aspects of design, commissioning and maintenance of the Adanac Aseptic Hub facility.
- To act as a Qualified Person (QP), responsible for assuring the quality of medicines as defined in the Human Medicines Regulation 2012/1916, on the Manufacturing Authorisation as required.To manage MHRA licence applications, MHRA Licence(s), liaising with MHRA and supporting regulatory inspections.
- Provides technical QA resource, advice and support to ensure GMP compliance at the manufacturing sites (Radiopharmacy & Adanac Aseptic Hub). This includes attendance at MHRA inspections which are essential for continuity of the Hubs manufacturing licence.
- Undertake an extensive programme of regular quality audit across pharmacy services in line with standards, reporting deficiencies to service managers. Ensure the pharmacy quality control laboratory service proactively identifies, and assesses the significance of, potential QA system failures, through daily and weekly monitoring. Advise service managers and the Chief Pharmacist on the required corrective action. Postholder is expected to spend a significant proportion (>40%) of their working week reviewing, developing and responding to quality audit.
- In conjunction with pharmacy and radiopharmacy technical services leads, advise senior pharmacy and Trust managers on matters relating to pharmaceutical aseptic preparation and manufacturing services, with regard to the Medicines Act 1968, and related standards. Initiate testing, monitoring and technical audits of radiopharmaceutical products and manufactured and prepared medicines.
- To act as a Responsible Person Import (RPi) on the Hub WDA(H).
- To ensure the delivery and maintenance of a GMP compliant aseptic manufacturing unit.
- Review, organise, update, manage and maintain the quality control laboratory facilities to meet service requirements and Good Laboratory Practice (GLP) ensuring all testing is performed by trained analysts on suitably qualified equipment using validated methods. Be responsible for expensive and complex technical equipment ensuring it is operating safely.
- To ensure a GMP (annex 15) compliant validation master plan is created to define the risk-based approach to the validation of facilities and equipment including the definition of ongoing maintenance and monitoring schedules.
- Provide specialist analytical / instrumental support and technical advice to the Trust pertaining to aseptic preparation, extemporaneous non-sterile preparation, radiopharmaceuticals and unlicensed medicines.
- Be responsible for the management and strategic development of the QA service and team, including responsibility for recruitment, appraisal, performance and absence management of staff.
- Responsible for Quality Assurance department’s budget including all necessary equipment purchases. High level Signatory for QA/QC budget involving selection of suppliers.
- Manage the specialist provision of the medical gas testing service according to UK / European standards.Ensure staff and contractors providing these services are appropriately competent and approved to undertake this work.Authorise ‘Permit to Use’ certification for medical gases in conjunction with the Authorised Engineer.
- Act as system administrator for remote temperature monitoring relating to the Wellcome Trust Clinical Research Facility, catering, pharmacy and Radiopharmacy.
- Manage the specialist provision, on contract, of quality assurance services and advice to other NHS and private pharmacy technical services units and sterile services units, including the preparation of formal audit reports.
- To be responsible for the QA systems in relation to Good Manufacturing Practice (GMP) including the design, build and maintenance of a pharmaceutical quality system.
- Assess and evaluate new equipment before purchase and before use in collaboration with pharmacy technical services managers and the Radiopharmacy Manager.
- Ensure the requirements of the Control of Substances Hazardous to Health (CoSHH) regulations are met for all aspects of pharmacy work and in relation to any use of medicines across the Trust.
- Design, implement and assess competence in training programs for QA staff and other pharmacy staff rotating through QA services. In addition, provide training to other pharmacy and Trust staff and university undergraduates in the principles of quality assurance, quality control and pharmaceutics. Act as a tutor or mentor for senior pharmacy or Trust staff.
- Manage the systems for all external drug and related medical device defects and recalls.
- Lead the preparation of tender documents and evaluation of tender submissions relating to the aseptic services and wider pharmacy.
- Leading and developing a highly skilled and expert team to oversee audit and assurance to ensure robust conformity to national regulatory and good practice standards.
- Communicates in complex technical areas with a wide range of people, including Senior Trust Managers, Contractors and Regulators.
- Needs to authoritatively interpret and explain Good Manufacturing Practice in order to influence practices in all pharmaceutical manufacturing and preparation sites. In addition, the post holder is required to communicate highly complex, technically demanding information to influence MHRA Regulatory Authority inspectors at inspections and accreditations.
- Communicates with Senior Clinicians, Trust Managers, Aseptic Network staff, Chief Pharmacists regarding highly complex technicalities of legislation and other QA related issues, whilst being mindful that there may be barriers to understanding. Routinely Chairs Corporate level meetings relating to aseptic services within the UHS and on occasion for the ICS/Regional aseptic services.
- Attends National and Regional Quality Assurance Meetings as required by NHSE, ICS and associated National Working Groups and Regional meetings as required.
- Communication of adverse findings to staff, Steering Board and purchasers of services requires tact. Confidentiality of data must be respected.
- Liaises with suppliers and manufacturers, to obtain scientific data relating to individual medicines with regard to their quality.