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Quality control - GC Analyst
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Quality control - GC Analyst
USV Private Limited- Posted 21 hours ago
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Job Description
- Perform daily analysis of raw materials, in-process samples, and finished formulations using Gas Chromatography (GC).
- Operate, calibrate, and troubleshoot GC instruments including FID, TCD, and HS-GC systems per standard SOPs.
- Prepare chemical standards, reagents, and samples accurately following cGMP, GLP, and pharmacopoeial guidelines (USP, IP, EP).
- Conduct method transfer, verification, and routine testing for residual solvents, assay, and organic impurities in formulations.
- Record, document, and review all analytical raw data and test results in logs or LIMS in compliance with 21 CFR Part 11 and data integrity standards.
- Report out-of-specification (OOS), out-of-trend (OOT), and atypical results promptly, assisting in lab investigations and root cause analysis.
- Maintain, clean, and perform preventive maintenance on GC columns, injectors, detectors, and gas supply systems.
- Manage inventory of GC column consumables, analytical standards, gases, and reference standards to ensure uninterrupted testing.
- Support internal, regulatory, and customer audit readiness by maintaining strict compliance with safety, quality, and environmental protocols.
- Write, revise, and execute SOPs, test procedures, protocols, and stability study reports for QC GC operations.
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