Quality control - GC Analyst

USV PRIVATE LIMITED; Gujarat; On-site; INR 400,000 - 700,000; Full time

Job summary

USV PRIVATE LIMITED seeks a skilled GC analyst in Gujarat to perform daily analysis of raw materials, in-process samples, and finished formulations using GC. You will calibrate and troubleshoot GC systems (FID, TCD, HS-GC) and prepare standards and samples per cGMP/GLP guidelines.

Responsibilities include method transfer, verification, and routine testing for residual solvents and impurities, with strict data integrity and documentation in LIMS.

Qualifications

• Knowledge of cGMP, GLP, and pharmacopoeial guidelines (USP, IP, EP).
• Experience operating GC instruments and maintaining analytical logs.

Responsibilities

• 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.

Skills

Quality compliance

Documentation

Audit readiness

Tools

GC instrumentation

FID

TCD

HS-GC

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.