Key Responsibilities
* Ensure that Commissioning, Qualification, and Validation (CQV) plans for GMP systems are developed, executed, and compliant with quality policies and SOPs
* Qualify and approve vendors involved in the project
* Review and approve CQV plans, protocols, reports, and related documentation such as URS, FAT/SAT, IQ/OQ
* Provide quality oversight and guidance on CQV documentation and change controls
* Lead and support staff on qualification and validation issues
* Manage deviations, change controls, and CAPAs, taking ownership for timely resolution and escalation when necessary