Sr. Officer - QC Analyst

USV; Poicha; On-site; INR 600,000 - 900,000; Full time

Job summary

USV in Gujarat, India seeks a GC-analytical specialist to perform routine and non-routine GC analyses of raw materials and products. You will support method development, validation, maintenance of GC systems, and data integrity in a cGMP environment.

The role requires documenting results, supporting OOS/OOT investigations, and coordinating stability studies while collaborating with QA, FRD, and Production teams.

Qualifications

• Experience with GC-based analysis and chromatographic techniques.
• Familiarity with ICH Q2(R1)/Q2(R2) guidelines.
• Knowledge of GLP/cGMP and SOPs.

Responsibilities

• Perform routine and non-routine GC analysis of raw materials, in-process samples, finished formulations, and stability samples.
• Assist GC method development, optimization, and validation per ICH guidelines.
• Troubleshoot and maintain GC instruments and perform column conditioning and leak checks.
• Ensure adherence to GLP, cGMP, SOPs, and pharmacopeial standards.
• Operate and manage CDS systems (e.g., Empower or ChemStation) with ALCOA+ and 21 CFR Part 11 compliance.
• Quantify residual solvents and volatiles using HS-GC as needed.
• Document results, review logbooks, and support OOS/OOT investigations.
• Perform calibration, PM, and IQ/OQ/PQ of GC systems and accessories.
• Coordinate stability testing and analyze trends under various conditions.
• Collaborate with QA, FRD, and Production for timely analyses and transfer of data.

Skills

Analytical method development

Method validation

Troubleshooting

Quality/compliance

Tools

GC instruments

HS-GC

CDS software (Empower/Che mStation)

Job description

Role & responsibilities

• Method Execution & Analysis: Perform routine and non-routine analysis of raw materials, in-process samples, finished formulations, and stability samples using Gas Chromatography (GC/HS-GC) equipped with detectors such as FID, TCD, or ECD.
• Method Development & Validation: Assist senior scientists or independently execute GC analytical method development, optimization, and validation/verification in compliance with ICH Q2(R1)/Q2(R2) guidelines.
• Troubleshooting & Maintenance: Perform basic maintenance, column conditioning, leak checks, detector cleaning, and technical troubleshooting of GC instruments to minimize downtime.
• Compliance & cGMP: Strictly adhere to Good Laboratory Practices (GLP), Current Good Manufacturing Practices (cGMP), standard operating procedures (SOPs), and pharmacopeial standards (USP, EP, IP, BP).
• Data Integrity & CDS Management: Operate and manage Chromatography Data Systems (CDS) such as Empower or ChemStation, ensuring 100% compliance with ALCOA+ principles, 21 CFR Part 11, and audit trail guidelines.
• Residual Solvents Analysis: Quantify residual solvents, volatile organic impurities (OVI), and organic volatile compounds in solid, liquid, or semi-solid formulation matrices using Headspace-GC (HS-GC).
• Documentation & OOS/OOT Investigation: Accurately document analytical testing data, review logbooks, prepare test reports, and participate in investigations for Out of Specification (OOS), Out of Trend (OOT), and Lab Incidents.
• Calibration & Qualification: Execute periodic calibration, preventive maintenance (PM), and operational/performance qualification (IQ/OQ/PQ) of GC systems and related accessories.
• Stability Testing: Coordinate stability testing protocols, execute interval-based stability sample analysis, and document physical/chemical stability trends under various storage conditions.
• Cross-Functional Coordination: Collaborate with Quality Assurance (QA), Formulation Research & Development (FRD), and Production teams to ensure timely sample analysis and smooth analytical transfer for commercial batches.