Qc Executive

Role & responsibilities

1. Operate, calibrate, and maintain Gas Chromatography (GC) instruments as per approved SOPs and established procedures.
2. Perform analysis of raw materials, finished products, in-process samples, and stability samples using GC.
3. Perform residual solvent analysis and other GC-related testing as per approved specifications and analytical methods.
4. Prepare mobile phases, reagents, standards, and sample solutions required for GC analysis.
5. Review chromatograms, system suitability results, and analytical data to ensure accuracy and compliance.
6. Perform instrument calibration, qualification, and routine performance verification as per schedule.
7. Maintain GC instrument logbooks, analytical worksheets, raw data, and laboratory records in compliance with GMP and GLP requirements.
8. Investigate Out of Specification (OOS) and Out of Trend (OOT) results and support laboratory investigations as per SOPs.
9. Follow data integrity requirements, including ALCOA+ principles, while generating, reviewing, and maintaining analytical data.
10. Ensure proper handling, storage, and traceability of reference standards, reagents, and chemicals.
11. Coordinate with QA and other QC sections for sample analysis, documentation, and timely reporting of results.
12. Ensure compliance with applicable GMP, GLP, safety requirements, and pharmaceutical quality standards.

Preferred candidate profile

• Hands-on experience with GC instruments and chromatographic data interpretation.
• Knowledge of pharmaceutical QC procedures and analytical method validation.
• Understanding of GMP, GLP, SOPs, OOS/OOT, and data integrity.
• Good documentation, analytical, and troubleshooting skills.