Kajal Rawat

• Reviewed batch manufacturing records through SAP and supported in-process control documentation for production activities.
• Prepared and reviewed Instrument Qualification protocols (DQ, IQ, OQ, PQ) for production equipment.
• Led initiation, preparation, and execution of change controls, deviations, CAPA, and market complaints as part of the plants quality
event process.
• Prepared, managed, and reviewed ISO-compliant documents including SOPs, work instructions, formats, charts, protocols, and
checklists; updated master documents periodically.
• Facilitated ISO 9001:2015 and GMP+ audits and FDA inspections with documentation support.
• Designed and monitored annual GMP, GDP, and entry-exit training programs for operations staff.
• Used SAP and EDMS for material and documentation control; contributed to natural colorant capsule development for veterinary
use.
• Drove continuous-improvement initiatives including RCA, 5S, Kaizen, and visual display management.

• Prepared and reviewed SOPs and analytical documents for API, intermediates, raw materials, and packaging materials, including
electronic test data sheets (e-TDS) and STPs.
• Compared and evaluated in-house specifications and methods of analysis against current pharmacopoeial monographs (USP, Ph.
Eur., JP).
• Supported internal QC audits with senior staff on a scheduled routine and organized GMP training sessions.
• Initiated and progressed change controls within the Quality Management System (QAMS) through to closure within specified
timelines.
• Worked with Caliber QAMS, SAP GUI, and EDMS for documentation initiation, completion, and filing via QAMS/SAP/L2LMS.