- HPLC Analysis like Drug Release, Drug Content, Impurity Analysis and maintaining documentation & Calibration of HPLC.
- Developing a recent product test analytical methods like Assay, Drug Release and Related substances.
- Maintain record of Working Standard, Reference Standard and Primary standard.
- Preparation of Working standard and their COA.
- Preparation of Analytical Method Validation Protocol.
- Analytical method validation of various test and it’s reporting.
- Prepare and verify HPLC calculation & results sheet as per study and maintain documents.
- Maintaining registers, log books, Instrument mapping records and all other documents/Records.
- Preparation of SOP.
- Preparation of Study protocols and reports.
- New equipment qualification &Review; of DQ/IQ/OQ/PQ.
- To Co-ordinate with outside laboratories, agencies as and when required.
Required Skills:
- Strong knowledge of HPLC analysis, Method Validation & Analytical Method Development.
- Hands-on experience in Assay, Dissolution/Drug Release & Related Substances/Impurity analysis.
- Good knowledge of HPLC calibration, troubleshooting & instrument qualification (DQ/IQ/OQ/PQ).
- Proficient in documentation, SOP preparation, protocols, reports & analytical calculations.
- Knowledge of Working/Reference Standards, COA preparation and laboratory compliance.