• Samples, tests and evaluates raw materials, API/HPAPI, finished goods and stability products against both chemical and physical parameters defined in the product specifications, in a timely manner.• Utilizes various laboratory equipment such as HPLC, UPLC, Spray Pattern Analyzer, Droplet Size Analyzer, GC, ICP, Ion Chromatograph, UV-Vis, Cary60 and FTIR spectrophotometer, Karl Fischer/Auto titrators, Break Loose Glide Force, Viscometer, Polarimeter and Osmometer in addition to wet chemistry techniques such as pH and titration.• Confirming all data obtained from the testing are appropriately interpreted, reviewed and reported with the help of EMPOWER3, InnovaSystem, ICP Expert II, Color, ChemStation, LabX, TestLoop and STARLIMS• Reviews testing performed by other analysts for compliance to SOPʼs and test methods.• Assisting in conducting MDI, DIR and OOS/OOT investigations.• Provide assistance in writing protocols, SOPs, test methods and final reports as required.• Supports stability program for new projects by testing stability samples against specifications in a timely manner.• Performs Technology Transfer for analytical methods from CDMO and R&D labs to Stability and Analytical Services department.• Follows GMP and regulatory requirements and supports all safety guidelines. Knowledgeable in Compendia, ICH and regulatory guidelines• Assisted in internal and external Audits along with Health Canada and USFDA audits• Demonstrates the Company Mission, Vision and Values Statements, policies, and current standard business practices.• Provides training for chemistry methodology and general chemistry techniques.• Maintaining inventory of standards, chromatographic columns and other required items by placing orders on timely manners.• Performs Raw Materials, API, Component Sampling as per request and requirements

• Performs required testing on raw materials, in-process, finished intermediates, final products, stability samples and other applicable samples using liquid chromatography• Experienced on HPLC/Karl Fischer/Dissolution/UV/FTIR methods• Skilled in Method Development, Validation, Transfer and Verification following guidelines• Confirming all data obtained from the testing are appropriately interpreted, reviewed and reported with the help of EMPOWER3 and LIMS• Ensuring that all samples are tested according to the established procedures and reported in a timely manner to meet production and regulatory requirements.• Performs OQ, PQ of laboratory equipment as required by the department's established calibration program and GMP requirements.• Troubleshoots instruments and helps to resolve OOS, CAPA

• Actively participated in Quality assurance activities such as product release, batch record review etc.• Maintained trending data of short term, long term and accelerated stability study products• Performed wet chemistry analysis as per USP/EP/BP/IP for APIs and Raw material• Performed packaging material analysis for Identification, thickness, diameter, and artwork compared to controlled documents and maintained the record for each product• Performed QC/Stability finished product samples analysis on HPLC/UPLC/UV/Dissolution/FTIR