| Description | 1.Ensure health & safety procedures are followed i.e. near miss accidents, workstation assessment etc. 2.Test product or validation samples, in accordance with approved procedures and in compliance with cGMP/ organizational standards to ensure Customer Service Levels are met or improved upon. 3.Handling of reference substance e.g SOP , stocks,….. 4.Employ working knowledge of the majority of analytical techniques, and specialist knowledge in others, to support their development for improved performance. 5.Minimize/eliminate own Cost of Non-Conformance, OOSs (with laboratory root causes) and Deviations (with laboratory root causes) and assist with analysis of incidents from colleagues to prevent reoccurrence, and guide associated team members to the same goal. 6.Act as process expert / SPOC for one or more allocated quality related processes 7.Assist with the qualification and validation of new or exist equipment to ensure that instrumentation is employed rapidly to become productive whilst meeting the Novartis/regulatory compliance requirements. 8.Perform the calibration activities for some specific QC equipment as appropriate (dissolution rate apparatus etc..) 9.Create and review QC Standard Operating Procedures and ensure competency and consistency within and across the PU. 10.Write and review methodology to ensure they are fit for purpose, and ensure Pharmacopoeial references are maintained as current through review of new BP, EP, USP, etc. and supplements. |
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