Experience in handling QMS activities, including Change Controls, Deviations, CAPA, OOS investigations, Market Complaints, and Vendor Qualification
JOB-2
Experience in Computerized System Validation (CSV), audit trail and system log reviews, user access management, periodic access reviews, backup and restore verification, and maintenance of GxP-compliant computerized systems. Knowledge of 21 CFR Part 11, EU GMP Annex 11, GMP, and data integrity.