Aseptic, Quality Assurance & Clinical Trial Pharmacist
1 month ago
Aseptic Services a) To assist the Aseptic Services Management team in the day-to-day management and provision of the cytotoxic re.....
Aseptic Services a) To assist the Aseptic Services Management team in the day-to-day management and provision of the cytotoxic reconstitution and aseptic services (including gene therapy) across sites. b) Ensure appropriate working conditions are adhered too and that the relevant principles of Good Manufacturing and Dispensing Practice, and those of the Health and Safety at Work Act are applied at all times. c) Ensure all professional aspects of technical services are incorporated into the chemotherapy and aseptic services procedure manuals and other aseptic services documentation. d) Ensure that aseptic services policies and procedures are adhered to, and production records and training documents are completed appropriately. e) To assist the Aseptic Services Management team in the delivery of local projects to optimise service provision and improve patient experience. f) Support the aseptic unit with any aseptic documentation that is required such as worksheet production, new product reviews, drug stability reviews and in-house drug monographs. f) Support the Aseptic Services Management team in working towards and maintaining quality standards g) Participate in the chemotherapy prescription verification rota Pharmacy Quality Assurance a) To assist the aseptic department to ensure the service is fully compliant with the relevant regulatory guidelines. b) Assist in maintaining the Quality Management System (QMS) in accordance with the unlicensed NHS facility requirements as documented in procedures and policies. c) Assist in reviewing and approving data generated from Micro testing (including verification, calibration and validation for methods and equipment/accreditation results) d) Supporting the Aseptic Services Management team with CAPAs and Change Controls as per Quality Assurance of Aseptic Preparation Services (QAAPS) and MHRA guidelines. e) Assist in completion of patient impact assessments and product quality risk assessments via deviation system f) Raise deviations to the Senior Management Team, assist in minor & major investigations and ensuring effective implementation of identified CAPAs. Support critical deviations.g) Daily review of the Environmental Monitoring System for the facility.
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