Position Overview The QC Chemist is responsible for carrying out analytical testing of raw materials intermediates finished formulations purified water and stability samples in compliance with Indian regulatory guidelines including WHO-GMP cGMP GLP and Schedule M The incumbent ensures that all testing activities meet quality standards required by CDSCO and applicable pharmacopoeias IP USP BP EP Key Responsibilities 1 Analytical Testing As per Indian Pharma Standards Perform analysis of raw materials intermediates and finished products as per Indian Pharmacopoeia IP and other approved methods Test stability batches following ICH CDSCO stability requirements Conduct instrument-based analysis using HPLC GC UV-Vis spectrophotometer FTIR Dissolution Apparatus pH meter KF titrator etc Carry out Water Testing Purified Water WFI as per IP limits and Schedule M requirements Ensure timely sampling and testing in coordination with Production QA and Warehouse 2 Documentation Regulatory Compliance Maintain test records as per GDP Positive Documentation Practice guidelines mandated by CDSCO Prepare COA test reports logbooks and maintain analytical raw data in compliance with Audit Trail requirements Ensure all testing is in line with WHO-GMP Schedule M guidelines applicable in India Report OOS Out of Specification OOT Out of Trend results and assist in root cause analysis CAPA Follow ALCOA principles for data integrity as required in Indian pharma plants 3 Laboratory Operations Ensure daily calibrations and proper operation of instruments as per respective SOPs Maintain reference standards working standards volumetric solutions and reagents as per Indian regulatory norms Participate in Method Validation Method Verification as per ICH Q2 guidelines Adhere to lab safety housekeeping and proper waste disposal as per local pollution control guidelines 4 Coordination Cross-functional Support Coordinate with QA for batch release document review and deviations Support Production in in-proce