1) Develop robust and reliable analytical methods for finished products. Prepare detailed method development reports and summaries in compliance with regulatory guidelines. 2) Analyze development and stability samples using validated methods to ensure formulation consistency and shelf-life evaluation. 3) Conduct analytical method verification for API and Finished products as per pharmacopoeia and regulatory requirements. 4) Facilitate smooth and documented method transfer to the Quality Control (QC) lab, including training, protocol preparation, and data review. 5) Perform exhibit batch sample analysis from initial to end-of-shelf-life stability points, including data compilation and review in compliance with regulatory requirements. 6) Develop and validate and method transfer for cleaning methods for manufacturing equipment to ensure compliance with cross-contamination control requirements. 7) Conduct multimedia dissolution profiling of formulations and prepare Comparative Dissolution Profile (CDP) reports for regulatory submissions. 8) Ensure compliance with GLP and GDP principles to maintain reliable, traceable data and accurate documentation as per regulatory requirements. 9) Ensure proper maintenance, calibration, and cleaning of laboratory instruments to maintain data accuracy and compliance.
