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SalaryThe post holder is responsible for the aseptic preparation, in accordance with GCP and GMP, of cell and gene therapy products, for use as licensed medicines or clinical trials, in the Cell, Gene and Tissue Laboratory including the organisational and service management requirements underpinning the processes. Support the releasing process which involves assessment and release of all advanced therapy medicinal products prepared by Newcastle Advanced Therapies under Section 10 and Regulation 37 exemptions. Providing pharmaceutical quality assurance (QA) support to Newcastle Advanced Therapies. Support the quality assurance processes for advanced therapy medicinal products prepared for use in the Trust. To have specific responsibilities as a Pharmacy Technician in Newcastle Advanced Therapies as delegated by the accountable pharmacist and/or Production Manager. Managing complaints regarding defective licensed medicines. Managing minor defects reporting within the Trust and collation of data for national reporting. Preparation and approval of documentation, e.g., standard operating procedures, batch manufacturing records, medicines specifications etc. Contribute to the education and training of staff in relation to QA activities. Carry out other duties, as required, to support a busy clinical service in the quality assurance and preparation of advanced therapy products across a range of regulatory standards including QAAPs, HTA, JACIE and the MHRA. The post holder will contribute to the provision and development of laboratory services, through innovative thinking and improvement mapping. As a flexible working friendly organisation, we want to be sure that you can work in a way that is best for us and for our patients, and for you. Speak to us about how we might be able to accommodate a flexible working arrangement. If it works for the service, we will do our best to make it work for you. Please note it is a requirement of The Newcastle upon Tyne Hospitals NHS Foundation Trust that all successful candidates who require a DBS for the post they have been offered pay for their DBS certificate. The method of payment is a salary deduction from your first months pay. You will be redirected to Trac to apply for the vacancy. Please expand the job details section and read all of the information before applying for the vacancy.
