• Handling of change control and CAPA. • Review of all engineering qualification documents (Equipment Qualification, Air Compressor’s qualification, PSA Nitrogen system qualification, HVAC qualification) Temperature mapping documents, Water system qualification documents. • Logging of OOS, OOT in system. • Co-ordination with cross functional department for providing required data to RA. • Preparation and review of site master file. • Preparation and review of Validation Master Plan. • Plant roun...