. • Responsible for management of stability studies and control sample.• Handling of QMS activities and market complaints. • Planning of daily stability activities, team management and stability trend analysis.• Ensure that the relevant procedures / SOPs are continuously assessed, suggest improvement if required and ensure compliance to the procedures.

• Planning of daily stability activities.• Investigation of Out of Specification and Out of Trend results• Review of stability data, validation, method transfer and calibration data.• Manage the database on a daily basis and monthly reporting of department metrics.• Ensure that the out of specifications and out of trend results on stability testing are efficiently captured.• Responsible for compliance in the laboratory, review of empower audit trials.• Handling the CAPA, Deviations, Change Controls.

• Review of stability, validation, method transfer and calibration data.• Investigation of Out of Specification and Out of Trend results.• Ensure that the out of specifications and out of trend results on stability testing are efficiently captured.• Responsible as a trainer to provide training to new joiner.• Adhere to laid down GLP, cGMP and Safety norms.• Ensure that the relevant procedures / SOPs are continuously assessed, suggest improvement if required and ensure compliance to the procedures.• Participate in allocated internal / external audits / self-inspections.

• Participate in allocated internal / external audits / self-inspections.• To perform analysis of Drug Products different tests such as dissolution, assay & impurity.• To perform calibration of instruments like UPLC, HPLC, dissolution testers, TOC analyzer, balances, pH meter, etc.• Columns and reference standards inventory within laboratory.

• To perform method transfer and validation analysis.• Preparation of method transfer protocol, validation protocol and final report.• Worked on audit point compliance of ANVISA Brazil.• Analytical support to registration batches.• Faced audit such as USFDA.

• Provide routine analytical support for scale-up and registration batches.• Testing of Drug Products, performing different tests such as dissolution, assay. & impurity testing using HPLC, UPLC, physicochemical testing of products, etc.• Following-up with production & IPQA for planning of testing.• Preparation of analytical test report, COA and hold time study report.

• Preparation of Stability Samples for Assay, Related Substances test and Dissolution.• Performing physiochemical test of Stability Samples like Hardness, LOD, Disintegration test etc.• Preparation of stability summery report and stability protocol as per ICH• Calibration of analytical balances and pH meter.