Qc Analyst

Role & responsibilities

• Perform analysis of Raw Materials (RM), In-Process Samples, Stability Samples, and Finished Products using GC and HPLC instruments.
• Prepare mobile phases, diluents, reagents, standards, and sample solutions as per approved analytical methods and SOPs.
• Operate, monitor, and maintain HPLC and GC systems, ensuring compliance with GMP, GLP, and Data Integrity requirements.
• Perform instrument calibration, system suitability tests, routine maintenance, and preventive maintenance activities.
• Troubleshoot chromatographic issues such as peak splitting, tailing, fronting, baseline noise, ghost peaks, retention time shifts, pressure fluctuations, and detector errors.
• Identify and resolve GC-related problems including gas leaks, unstable flame, poor resolution, column contamination, injector issues, and detector malfunction.
• Conduct method validation, method verification, method transfer, and analytical method development activities as assigned.
• Review, process, and interpret chromatographic data; investigate OOS/OOT results and support CAPA implementation.
• Maintain analytical records, logbooks, worksheets, calibration records, and test reports in accordance with regulatory requirements.
• Support internal/external audits, ensure laboratory compliance, and provide analytical troubleshooting support to QA, Production, and R&D teams