Sr. Officer - QC Analyst

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.