Key Responsibilities
Perform analysis of raw materials, intermediates, finished products, stability samples, and cleaning validation samples using HPLC.
Prepare analytical solutions, mobile phases, reagents, and standard solutions as per approved procedures.
Operate, calibrate, and perform routine maintenance of HPLC systems and other analytical instruments such as UV-Visible Spectrophotometer, FTIR, Dissolution Apparatus (if applicable), pH Meter, and Karl Fischer Titrator.
Execute analytical method validation, method verification, method transfer, and method development support activities.
Review chromatograms, analytical data, and calculations to ensure accuracy and compliance with specifications.
Prepare and maintain laboratory documentation, including analytical worksheets, logbooks, calibration records, and instrument usage records.
Investigate Out-of-Specification (OOS), Out-of-Trend (OOT), laboratory incidents, and deviations, and support root cause analysis and CAPA implementation.
Ensure compliance with cGMP, GLP,



data integrity (ALCOA+ principles), and laboratory safety requirements.
Support internal audits, customer audits, and regulatory inspections.
Participate in instrument qualification (IQ/OQ/PQ) and preventive maintenance activities.
Coordinate with Production, QA, and other departments for sample receipt, testing, and timely release.
Ensure proper handling, storage, and disposal of laboratory chemicals and reference standards.

Required Technical Skills
Hands-on experience with HPLC operation, troubleshooting, and data interpretation.
Working knowledge of chromatographic techniques and pharmaceutical analytical testing.
Familiarity with analytical software such as Empower, OpenLab CDS, LabSolutions, or similar chromatography data systems.
Knowledge of cGMP, GLP, ICH guidelines, pharmacopeial requirements (USP, EP, IP, BP), and data integrity.
Positive documentation practices (GDP).

📌 Officer To Senior Officer Qc Hplc Gujarat
🏢 Cadila Pharmaceuticals
📍 Gujarat