Job
Description
To conduct and document analytical method validation (AMV), method verification, and method transfer activities for raw materials, in-process samples, and finished pharmaceutical products in compliance with ICH Q2(R1) , GMP , and regulatory standards . Key Responsibilities Analytical Method Validation Perform validation of analytical methods as per ICH Q2(R1) guidelines for: Assay and related substances (HPLC, UV) Dissolution, content uniformity, residual solvents (GC) Identification and other physicochemical parameters Conduct validation parameters: specificity, accuracy, precision, linearity, robustness, LOD/LOQ, system suitability, etc. Document results in validation protocols and summary reports. Method Verification Verify compendial methods (IP/BP/USP/Ph.Eur.) for RM/FP/IP samples. Confirm suitability of method for intended use before routine application. Prepare method verification reports and submit for review/approval. Method Transfer Participate in analytical method transfer (AMT) from R&D or third-party units. Execute comparative testing for transferred methods and compile transfer protocols. Coordinate with sending/receiving sites for method harmonization and troubleshooting. Instrument Handling Operate and troubleshoot instruments such as: HPLC (Empower, LabSolutions, Chromeleon) GC (Headspace, FID) UV-Visible Spectrophotometer FTIR, Dissolution Apparatus, TOC (if applicable) Documentation & Compliance Prepare and review: Validation protocols and reports Analytical worksheets and system suitability documents Adhere to GMP, GLP, and ALCOA+ principles. Maintain instrument logs, change controls, and CAPA logs where applicable. Audit Readiness & Regulatory Support Ensure all AMV data is audit-ready and compliant with regulatory expectations. Support in regulatory inspections (USFDA, MHRA, WHO-GMP, etc.). Address audit observations related to analytical validation. Instruments & Software Used HPLC, GC (Headspace, FID) UV-Vis Spectrophotometer, FTIR Dissolution Testers CDS Software: Empower / LabSolutions / Chromeleon Education :M.Sc. (Analytical / Organic Chemistry) / M.Pharm
