The Documentation and IV Execution Lead is responsible for implementing and supporting CQ related Documentation, including but not limited to URS, TS, FS Oversight, Development of CQ Plan, Execution of EDRA,Gap Assessment, DQs and Preparation and Post Execution approval of CQ Docs (FAT, SAT, IV, SU, OFT, IQ and OQs) within the KNEAT Platform In line with PDP and Client C+Q requirements, the KNEAT Documentation Lead shall adhere to the Baseline Schedule and ensure Technical and GDP Compliance with URS and Design Specifications. Coordinating development and approvals with the Client and with other disciplines including Vendors, Automation, E+I, and USER in line with Workflow.