Warning letters, 483s, Recalls, Import Alerts, Audit observations
Team Lead – Commercial Finished & Stability, Sample Management and planning, document review, audit trail
Life cycle management of product registrations, dossiers, handling of variations for Europe
Regulatory submission of new products, renewals, variations, response to queries and Life cycle management for
Monitoring, auditing and assuring the quality of operational aspects of the Facility as per Good
Testing, inspection, and data analysis, Physicochemical, Biochemical assays and analysis for batch release, stability studies
IPQA activities, area line clearance, inprocess sampling, review of documents, cleaning
Perform method verification/validation of compendia/pharmacopeial updations, Method verification of SDC’s (Supplier Driven Changes) method. Method
Responsible for all stability Management activities., Documentation and Training coordination. Initiate and evaluate various investigations
