An exciting opportunity has arisen for an experienced aseptic services pharmacy technician to lead and manage the preparation and delivery of safe and high quality Systemic Anti-Cancer Therapy from Barnet Hospital Production Unit. The role will also involve implementation of new regulatory guidance as well as national agenda items that concern pharmacy aseptic services. The role will involve managing the Pharmaceutical Quality System to ensure that controlled documentation is updated to ensure safe and consistent practice, as well as managing Deviations effectively and any associated Change Controls which may arise from them. They will also have significant involvement with self-inspection of the department to ensure continuing compliance with QAAPS standards and ensure that the contamination control strategy for the facility is implemented and risks identified and safely mitigated. The postholder will also work closely with the Education and Training coordinator to ensure that team accreditations and validations are undertaken in a timely manner to ensure safe preparation and delivery of treatment, as well as manage validation activities to provide assurance of safe and consistent processes, equipment and operator technique. They will also be involved with periodic review of Key Performance Indicators as well as oversee the environmental monitoring programme.
* To manage and be responsible for all aspects of the day-to-day delivery of the production service at Barnet Hospital, ensuring that the service complies with all current regulatory requirements of Section 10 pharmacy aseptic preparation, and operating within the bounds of COSHH, Health and Safety, GMP, GCP and QA regulations.
* To develop and maintain all controlled documentation such as worksheets and standard operating procedures, in liaison with the Operational Lead Pharmacist and RFH Quality Assurance. To ensure that all relevant documentation is reviewed on a regular basis, updated as necessary and all out-of-date documentation is taken out of circulation.
* To ensure all quality exceptions and deviations from SOPs are reported to Quality Assurance via the EQMS quality management system, are appropriately documented and that resolution of problems are undertaken in a timely fashion.
* To ensure that all environmental monitoring is carried out at the required time and frequency, by appropriately trained staff.
* To ensure that the clean rooms are operating within specification prior to manufacture.
* The post-holder may need to work cross-site between Barnet and Hampstead sites and in future any other NHS hospitals that joins the Group Model. If in future the services are rationalised to one site then the post holder will be expected to work from that base.
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