Key Responsibilities

• Perform routine and non-routine analysis of samples using HPLC as per approved test procedures and pharmacopoeial methods.
• Conduct assay, dissolution, related substances, and content uniformity testing for OSD formulations.
• Operate and maintain analytical instruments including HPLC, UV-Visible spectrophotometer, dissolution apparatus, pH meter, and balance.
• Prepare mobile phase, buffers, standards, and sample solutions as per SOPs.
• Review chromatographic data, integration, and ensure accuracy of analytical results.
• Perform system suitability tests and ensure instrument readiness before analysis.
• Maintain laboratory notebooks, electronic records, and documentation as per GMP and GDP requirements.
• Handle calibration and routine maintenance of HPLC and other QC instruments in coordination with Engineering/Calibration teams.
• Investigate Out-of-Specification (OOS), Out-of-Trend (OOT), and laboratory deviations.
• Support method validation, method transfer, and stability studies.
• Ensure compliance with cGMP, GLP, data integrity (ALCOA+ principles), and regulatory guidelines.
• Participate in internal audits, regulatory inspections, and quality system improvements.
• Ensure proper handling and disposal of chemical waste as per safety guidelines.
• Maintain laboratory cleanliness and ensure compliance with safety procedures.