Job Description:

The job description is as below:

To perform High Performance Liquid Chromatography analysis for various pharmaceutical tests including Related Substances, in compliance with 21 CFR Part 11 and cGMP guidelines. The role includes calibration, troubleshooting, integration, and data review activities related to HPLC.

Key Responsibilities:
- Perform routine and non-routine HPLC analysis for Assay, Related Substances, Content Uniformity, and other quality control tests.
- Strong analytical method validation knowledge and performance.
- Prepare sample sets, analytical methods, and sequence tables for HPLC runs.
- Ensure all HPLC analyses comply with 21 CFR Part 11, including audit trail review and electronic data integrity.
- Review and approve HPLC integration and raw data per method-specific parameters.
- Conduct HPLC calibration and performance verification as per standard procedures.
- Identify and troubleshoot HPLC-related issues including baseline noise, pressure issues, leakages, and pump errors.




- Maintain complete and accurate records of all QC activities in accordance with cGMP and data integrity principles.
- Participate in deviation investigations, OOS, and change controls as required.
- Support during regulatory audits and internal inspections by providing required documentation and clarification.
- Coordinate with QA, Production departments for sample and method transfers.
- Maintain proper documentation of instrument logs, calibration records, and analytical reports.
- Ensure timely completion of assigned tasks to meet release timelines.

Qualifications & Experience:
- B.Pharm / M.Pharm / M.Sc. in Chemistry or related field.
- Minimum 1 -2 years of hands-on experience with HPLC analysis in a pharmaceutical QC workplace.
- Sound knowledge of HPLC troubleshooting, method development, and instrument maintenance.
- Working knowledge of Empower / LabSolutions or other chromatography data systems (CDS).
- Familiarity with 21 CFR Part 11 compl

📌 Looking for QC Chemical Officer/Executive for Pharma company based at Ankleshwar
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📍 Ankleshwar