- Perform analysis of Raw Materials, In-process Samples, Finished Products, Stability Samples, and Validation Samples using HPLC.
- Prepare and standardize reagents, volumetric solutions, and mobile phases as per approved procedures.
- Operate, calibrate, and maintain HPLC instruments and ensure proper documentation.
- Review chromatograms and analytical data for accuracy and compliance.
- Maintain analytical records, logbooks, and worksheets in accordance with GDP and GMP requirements.
- Participate in method validation, method transfer, and analytical method verification activities.
- Perform troubleshooting of HPLC-related issues and coordinate with the engineering/vendor team when required.
- Ensure compliance with SOPs, GLP, Data Integrity,
and regulatory requirements.
- Maintain cleanliness and housekeeping of the QC laboratory and instruments.
- Support investigations related to OOS (Out of Specification), OOT (Out of Trend), and laboratory deviations.
- Ensure timely completion of testing activities and report results to the concerned department.
- Participate in internal audits, regulatory inspections, and training programs.