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Specialist Technical Officer
2 weeks ago
Aseptic Preparation To prepare and prioritise cancer chemotherapy and other medicines for injection, using aseptic technique in laminar airflow cabinets or isolator technology, providing all necessary in-process checks, within the clean room environment, isolated from direct supervision. To work unsupervised if necessary in the preparation of cancer chemotherapy. To supervise the preparation of aseptically prepared injectable medicines and to complete the cleanroom supervision in pharmacy technical services accreditation provided by pharmacy workforce development southwest. To prepare cancer chemotherapy for intrathecal use according to Department of Health guidelines, local Trust policy and departmental procedures.
To complete the initial check of cytotoxic and non-cytotoxic injectables and parenteral nutrition, completing the in-house competency assessment and the pharmacy workforce development southwest accredited pre and in process checking accuracy accreditation. To follow carefully all standard operating procedures to ensure all products are made safely and efficiently in accordance with Good Manufacturing Practice Guidelines. To complete any environmental monitoring or operator validation tests and to assist in the planning of new and on-going validations of colleagues. Documentation To organise and schedule the daily workload, considering capacity within the unit and patient requirements, under the direction of the senior pharmacy technicians.
To prepare the first draft of master product documentation for new products and the first draft of new standard operating procedures under the direction of the senior pharmacy technicians. To complete, maintain and file all relevant documents, records, and reports. To participate in the preparation of clinical trials, completing all necessary documentation as described in the study protocol. To prepare product documentation and labels, with calculations using appropriate software programmes.
Quality Assurance To organise and schedule the daily workload, considering capacity and the requirements of aseptic unit colleagues, under the direction of the senior pharmacy technicians. To organise the environmental monitoring schedule to ensure the aseptic unit is working within GMP parameters. To support the senior pharmacy technician, training with the organisation of routine validation procedures including aseptic material transfer, aseptic changing and aseptic hand-washing techniques. To accurately read and interpret all microbial plates and samples.
To record results and to draw attention to any which fall outside of action levels and other spurious or unusual data. To record results on to various computer programmes. To manipulate and present environmental data in an orderly and understandable manner. To check that it conforms to pre-determined limits and to notify the Production Services Manager/Deputy and Accountable Pharmacist/Deputy if it does not.
To report any problems or potential problems with the cleanliness or maintenance of clean rooms to the Production Services Manager/Deputy and Accountable Pharmacist/Deputy. To complete a suitability assessment of unlicensed medicines based on the criteria outlined in the trust unlicensed medicines policy, including obtaining certificates of analysis or conformity from suppliers as required. To ensure that all settle plates, broth, and other media are incubated for the correct length of time and at the correct temperature, in accordance with GMP guidelines. To report any problems and issues with the cleanliness or maintenance of the cleanrooms to the senior team and be proactive in managing any remedial works required, through the permit to work system.
To ensure that temperature monitoring for the aseptic unit and associated area is carried out ensuring that all systems, cold stores, fridges, and freezers are working appropriately. To be proactive in managing any temperature excursions and to ensure that the Production Services Manager/Deputy and Accountable Pharmacist/Deputy is informed of any non-compliance issues. To participate in inter laboratory analysis schemes as appropriate. Training and Education To train and carry out competency assessments of designated aseptic team colleagues under the guidance and with the support of the Senior pharmacy technician for Education and Training To support the Senior Pharmacy Technician for Education and Training in the management and oversight of induction, training and personal develop plans of the aseptic services team To act as a mentor and appraiser to colleagues working in aseptic services and support them in career progression and with their wellbeing To train and mentor colleagues who rotate into aseptic services as part of a training programme, to include pre-registration trainee pharmacy technicians, pre-registration trainee pharmacists, work experience students, university students, and new rotational pharmacists To co-operate and participate in any traini
