- Perform HPLC analysis of raw materials, packing materials, in-process and finished products.
- Operate and maintain Shimadzu HPLC systems.
- Perform analysis as per approved STP, specifications and pharmacopoeial methods.
- Preparation of mobile phase, standards and samples.
- Review chromatograms and calculate results accurately.
- Handle system suitability, calibration and instrument troubleshooting.
- Maintain laboratory records, worksheets and analytical documentation.
- Follow GMP, GLP and safety requirements.
- Support investigation of OOS/OOT results and laboratory deviations.
- Ensure proper documentation and data integrity as per applicable procedures.
Required Skills:
- Hands-on experience with Shimadzu HPLC.
- Positive knowledge of HPLC troubleshooting and chromatographic techniques.
- Knowledge of pharmaceutical QC documentation and GMP practices.
- Experience in an Injection/Parenteral manufacturing plant will be preferred.