Senior Pharmacy Lab Quality Analyst
CurrentQuality Control (50% Annual Time): Able to approach multiple analytical tasks, conduct analytical tests and run optimum day-to-day operations efficiently and accurately. Conduct quality assurance by wet chemistry testing and operating Shimadzu laboratory instruments with LabSolutions DB version correctly including Gas chromatography (GC-2010, 2030 with FID & Headspace systems), Ultraviolet-Visible spectroscopy (UV-Vis), Karl Fisher, Atomic Absorption Spectroscopy (AAS) and Fourier Transform Infra-red (FTIR) Spectroscopy according to the GMP and TGA requirements. Support with new LIMS implementation Support Quality Assurance manager in analyzing test results to identify trends and potential issues, and issue 10 to 20 daily reports.Quality Management System (35% Annual Time): Ensure record keeping for QC is maintained to the required standard Oversee and maintain those areas that relate to technical processes and procedures. Prepare and finalize Standard Operation Procedure (SOP), Meeting minutes, Certificates of Analysis (COA), Reports and Job Issues for accurate documentation in accordance with good manufacturing practices (GMP). Manage the Calibration & Method Validations of Test Centre equipment in accordance with the Australian Standards, and maintain the register. Coordination of new equipment set-up. Attended basic training in Shimadzu ICPMS and GCMS systems. Manage the consumables stock, ordering and receipting Participate in investigations of customer complaints to evaluate any technology/testing-related aspects of the complaint. Training (15% Annual Time) Training new staff in an efficient, accurate and professional manner. Manage the training of new staff, and current staff on new equipment. Develop internal and external training process Be a team player and help each other within lab permissible tolerance.
