Perform analysis of raw materials, intermediates, in-process samples, solvents, recovered solvents, and finished APIs as per approved specifications and analytical methods. Carry out testing using techniques such as: HPLC GC UV-Visible Spectrophotometer FTIR KF / moisture determination pH Titration Melting point Specific gravity and other applicable physical/chemical tests. Perform testing of solvent recovery samples for purity and relevant quality parameters. Ensure testing is performed within defined timelines. 2. Instrument Handling Operate analytical instruments as per approved SOPs. Perform routine instrument checks and ensure instruments are in calibrated/qualified status before use. Maintain instrument logbooks and usage records. Report instrument malfunction, abnormal results, or breakdowns to the supervisor. Assist in instrument calibration, qualification, and troubleshooting activities. 3. Documentation & Data Integrity Record analytical results accurately in worksheets, laboratory notebooks, LIMS, COA, and other approved formats, as applicable. Follow Good Documentation Practices (GDP) and data integrity principles. Ensure all raw data, chromatograms, calculations, observations, and results are complete and traceable. Review analytical calculations and documentation before submission. Maintain proper records of standards, reagents, solutions, and reference materials. 4. OOS / OOT & Investigation Immediately report Out-of-Specification (OOS), Out-of-Trend (OOT), atypical, or abnormal results. Support laboratory investigations and root-cause analysis. Participate in OOS/OOT investigations as per approved procedures. Ensure investigation activities and supporting analytical data are properly documented. 5. Reagents, Standards & Laboratory Management Prepare and standardize reagents, volumetric solutions, mobile phases, buffers, and other laboratory solutions as per approved procedures. Maintain proper labeling, storage, and expiry/retest information for reagents and solutions. Maintain reference standards and working standards as per applicable procedures. Monitor laboratory consumables and inform the supervisor regarding shortages. 6. Stability & Validation Support Perform testing of stability samples according to approved stability protocols. Support method validation, method verification, analytical method transfer, and cleaning validation activities as required. Generate and maintain analytical data and supporting documentation. 7. GMP & Safety Compliance Follow applicable GMP, GLP, SOP, EHS, and laboratory safety requirements. Handle chemicals, solvents, acids, bases, and hazardous materials using appropriate PPE and safety procedures.
