Warning letters, 483s, Recalls, Import Alerts, Audit observations
Perform In-process Process QA activities, the environmental monitoring of facilities and Utility systems, Audits and
Assure individual compliance with all concerned regulatory requirements, GxP’s and applicable department programs, including training,
Equipment and Facility Validation, Preparation of VMP, coordinate execution, Preparation and review of validation documents
To Manage the entire qualification and validation activities in the site specifically related to equipment/utility
Planning, execution, review, QA support and lifecycle management of product manufacturing and control. Oversee storage
Manage compliance programs associated with Contract Manufactured products, Assessment of Contract Manufacturing Organizations and 3PL
Responsible for monitoring, auditing and assuring the quality of operational aspects of the Facility according
