Specialist Technical Officer Quality Control

2 months ago

Plymouth, United Kingdom University Hospitals Plymouth NHS Trust Full time

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. To supervise Assistant Technical Officers, Senior Assistant Technical Officers, and students working within aseptic services.

To clean the pharmacy aseptic suite and support rooms following standard operating procedures and using specific methods of cleaning, ensuring appropriate quality control samples are taken and cleaning logs filled out. To take part in an on-call duty rota to assist the on-call pharmacist to include, providing information relating to queries, preparation of emergency medicines and preparation of treatments that are unable to be made in advance.

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