Deepa Mohan

1. Review and Approval of QC documents ( Calibration Reports, Raw materials Reports, Inprocess Reports,Finished goods, Stability Reports, Method Transfer Reports, Method Validation reports).

2. Review of Audit Trials for QC instruments.

3. Preparation of Stability protocols and Stability Compilation reports.

4. Planning and execution of Stability studies

5. Handling of OOS,OOT, Deviations, Change control, RCI and CAPA implementation.

1. Preparation and Execution of Validation Protocols pertaining to Assay and Dissolution testing.

2. Preparation of Validation Reports.

3. Preparation and Execution of Analytical Method transfer protocols.

4. Preparation of Analytical Method Transfer Reports.

1. Product development of NDA project.

2. Analysis of Raw materials, Inprocess and Finished goods.

3. Analysis of Stability Samples and Regular Analysis for Product Development.

4. Performing Calibration of various Instruments ( HPLC, UPLC, Dissolution, UV Spectrophotometer, pH meter, KF Titrator )

1. Performed Complete Analysis of API for Vendor selection.

2. Performed Method transfer of Finished product to QC Laboratory.

3. Instruments Handled - HPLC, UPLC, Dissolution Apparatus, Malvern Particle size Analyzer, PAMAS Particle Counter, Polarimeter, Atomic Absorption spectrophotometer, Friability Test Apparatus, UV-Vis Spectrophotometer, IR Spectrometer, KF Titrator etc.,