Authoring and managing the following (with input from SMEs): C&Q Plan & Risk assessments, Automation Validation Plans, URS documentation / Data Integrity Assessment/ System Impact Assessment / RTMs, FAT/SAT documentation, IOQ documentation and Summary Reports.
Monitor FAT/SAT and IOQ execution activities, proactively identifying protocol execution issues and providing solutions.
Ensure FAT/SAT and IOQ execution aligns with the intent of the test scripts.
Executing tests on lines, systems and equipment that are CSV related.
Ensure all automation deliverables comply with applicable regulations and industry best-practice guidance such as 21 CFR Part 11, EudraLex Annex 11, and GAMP 5.
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