Microbiology Team Leader
Current• Plan, carry out and report validation and testing of sterile products to meet agreed schedule, including in-process and finished products covering unlicensed medicines, investigational medicinal products, and Stryker antibiotic bone cement licensed products:o Sterility test materials inside a gassed isolator by membrane filtration or direct inoculation.o Biological assays on antibiotics.o Pre-filtration bioburdenso Endotoxin by KQCL• Plan, carry out and report testing to support validation of sterile production facilities e.g. oven validations, isolator qualification.• Plan, carry out and report testing of media fills.• To perform all laboratory activities safely, in accordance with GMP, and to agreed timelines.• Co-ordinate the investigation of out of specification results, preparation of resulting reports and liaise with QA.• Preparation or review of standard operational procedures.• Qualification/calibration of laboratory equipment as agreed with line manager.• Assistance in the conduct of deviations and investigational or validation work where appropriate.• Assistance with temperature monitoring of incubators/fridges, basic characterisation of bacteria, yeast and moulds, reading and recording of agar plates and broths, inspection of broth fill units and biological indicator tubes, reading and reporting of media fills, as required.• To perform any other duties which may be required.
