Role & Organizational Overview
The Analyst position in Quality Control at GSK (located in Nashik, Maharashtra) plays a critical role in supporting the site's pharmaceutical manufacturing operations. Operating in a regulated QC laboratory environment, this role involves performing analytical testing, stability study execution, instrument operation, sample management, and regulatory compliance adherence to ensure safe, high-quality medicines reach patients worldwide.
Core Responsibilities
Analytical Testing & Execution: Perform routine and non-routine QC analysis on raw materials, stability samples, Creams, Ointments, and Tablet formulations using standard pharmacopoeial procedures (USP, IP, BP, EP).
Instrument Operations & Maintenance: Operate, calibrate, troubleshoot, and maintain core analytical instruments including HPLC, UPLC, UV-Vis, FTIR, Dissolution apparatus, Karl Fischer Titrator, and pH Meters.
Stability Program Management: Execute stability sample testing according to approved stability protocols and schedules. Perform trend analysis, shelf-life evaluations, and stability chamber monitoring.
Quality Investigations & Compliance: Support root-cause investigations into Out of Specification (OOS), Out of Trend (OOT) results, laboratory incidents, deviations, and Corrective/Preventive Actions (CAPA).
Documentation & Data Integrity: Maintain accurate, audit-ready laboratory records, logbooks, worksheets, and analytical reports adhering to ALCOA+ data integrity principles and cGMP/cGLP standards.
Digital & Software Utilization: Utilize electronic laboratory tools and chromatography data systems such as Empower CDS and SLIMS for data acquisition, processing, and reporting.
Technical & Domain Standards
Strict adherence to cGMP, GLP, GxP regulations, ICH Stability Guidelines, and data integrity principles (ALCOA+).
Expertise in analytical method execution: Assay, Related Substances, Dissolution, Water Content, pH, and Identification testing.
Active involvement in method transfers, validations, continuous improvement (Lean), and internal/external regulatory audit preparation.
Leadership & Business Impact
Ensures product quality, stability compliance, and release readiness for commercial pharmaceutical batches produced at GSK Nashik, safeguarding global patient health and regulatory compliance.
