Analytical method Development for Assay, Related Substances, Analytical Method Validations, Impurity Isolation and Characterization, Reference Standard Preparation.

HPLC, GC, KF, Dissolution, Disintegration, Friability, UV, Melting Point, Auto-titrator, pH meter, Weight Balance, Ultrasonicator, Raw material, In process, Intermediate, Finished Products Analysis, Qualification and Calibration of Instrument, Stability Studies.

Regulatory Guidelines, cGMP, GLP, GDP, 21 CFR Part 11, ICH Q7, SOP Preparation, Change Control, Handling of Non-Conformance, Incidences, Deviation, Market complaint, OOS, OOT, IPQA, Internal Audits, QMS, Quality documents preparation, Document control.

Practical knowledge about Process Research, including literature search, Feasibility studies, Process Optimization and Scale-up, Lab Process Validations, Column Chromatography, TLC Analysis.

Operations related to manufacturing plant under cGMP, Batch Manufacturing Records, Process Validations, Cleaning Validations.