Deepa N. Email & Phone Number

Streamlined and formalized Document Control workflows and processes within e-doc management system, QT9, and paper based system. Oversaw and managed document workflows, from initiation to publish for use, revision control, to retirement and archive. Maintained electronic and paper training process for all GxP personal and functions. Established and.

Facilitated document workflows, from draft initiation to publication for execution to training. Format, and prepare all GxP procedural documents and forms. Support implementation of eDMS and eLMS, Configuration and Validation of systems, execute Test Scripts. Supported FDA Inspections, Prep war room activities and document requests.Prepare New Hires with.

Cambridge, MA

Processed and maintained internal procedural documents, along with all gxp documents including training records and vendor management docs. Performed QA New hire Onboarding. Supported eDMS and LMS system validation, testing, and migration activities. Oversaw archive room build out and established archive process.

Processed and maintained various controlled gxp documents and logbooks. Controlled paper document workflow, from issuance to archive. Maintained paper archive system, tracking and maintaining documents through various databases.

Issued Batch Records and Forms, Logbooks and labels. Reviewed Batch Records and disposition documents. Tracked and maintained databases, filed and organized batch records and other gxp documentation.

Created training files and assisted in issuance of controlled records. Archived completed documents and assisted in off-site archival activities.

Education record

Criminal Justice