This role will support the Quality Control SDWT/Hub for testing of incoming raw materials, in-process drug substance/drug product, final drug products, stability samples, and environmental monitoring of the controlled manufacturing areas and utilities at the new single-use multi-product biotech facility. This facility will manufacture antibody-based therapies. The overall responsibility for this role will be to support the Quality Control testing function, ensuring compliance with cGMP and corporate regulations. This is a critical role within the MS&T organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for our patients. The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists. The Laboratory Business System Analyst will work across the site self-directed work teams and hub teams to identify and resolve issues to allow the site to deliver on our committed culture that supports Quality, EHS, Learning, and Continuous Improvement.
This role is associated with the data management systems for instrument control in the laboratories, this includes but is not limited to Labware LES (LIMS + Execution System),Lonza MoDa and Waters Empower. Below activities are associated with these systems.
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