Key Responsibilities:

• Perform and supervise analysis of raw materials, in-process, stability, and finished injectable products using HPLC
• Prepare mobile phases, reagents, standards, and sample solutions as per approved analytical methods
• Operate, calibrate, and maintain HPLC systems and other lab instruments (UV, Dissolution, pH meter, etc.)
• Execute method validation, method transfer, and verification activities
• Review analytical data, chromatograms, and reports to ensure accuracy and compliance
• Handle OOS (Out of Specification), OOT (Out of Trend), deviations, and investigations
• Ensure data integrity and compliance with regulatory guidelines (USFDA, MHRA, WHO, etc.)
• Maintain and review GMP/GLP documentation, including analytical worksheets and reports
• Coordinate with production and QA teams for smooth workflow and batch release timelines
• Support internal/external audits and regulatory inspections
• Ensure proper laboratory housekeeping and adherence to safety practices