Warning letters, 483s, Recalls, Import Alerts, Audit observations
Testing, inspection, and data analysis, Physicochemical, Biochemical assays and analysis for batch release, stability studies
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
Handle deviations, investigations, and act as SME during audits
Under guidance of Supervisor or senior chemist, responsible for performing all activities in ARD-Test Centre
Process Engineering in Active Pharmaceutical Ingredient (API) development, scaling up or down technologies to meet
Compilation and review of dossiers, DMF for US, Europe, Japan and other markets , Evaluation
Under guidance of Supervisor or senior chemist, responsible for performing all activities in ARD-Test Centre
