Key Responsibilities:

• Perform and supervise analysis of raw materials, in-process, stability, and finished injectable products using GC
• Conduct residual solvent analysis and volatile impurity testing as per pharmacopeial methods
• Prepare standards, reagents, and sample solutions as per approved methods
• Operate, calibrate, and maintain GC instruments (FID/Headspace GC preferred)
• Execute method validation, method transfer, and method verification activities
• Review chromatograms, analytical data, and reports for accuracy and compliance
• Handle OOS (Out of Specification), OOT (Out of Trend), deviations, and investigations
• Ensure data integrity and compliance with GMP, GLP, and regulatory guidelines (USFDA, MHRA, WHO, etc.)
• Maintain proper documentation, including analytical worksheets and reports
• Support internal audits, regulatory inspections, and qualification activities
• Coordinate with QA and Production teams for timely batch release
• Ensure laboratory safety, calibration schedules, and housekeeping standards