Quality Control (QC HPLC, GC & Stability) | Experience: 2–6 Years

Roles & Responsibilities
Perform analysis of Raw Materials (RM), In-Process (IP), Finished Products (FP), and Stability samples using HPLC, GC, UV, Dissolution, and KF.
Operate, calibrate, and troubleshoot HPLC, GC, and other analytical instruments.
Prepare mobile phases, reagents, standard solutions, and test samples as per SOPs.
Review chromatograms, calculate results, and ensure compliance with specifications.
Conduct stability testing as per ICH guidelines and approved stability protocols.
Perform instrument calibration, qualification, and preventive maintenance activities.
Investigate OOS, OOT, deviations, and laboratory incidents, and support CAPA implementation.
Maintain laboratory documentation, logbooks, and analytical records in compliance with cGMP, GLP, GDP,



and ALCOA+ Data Integrity.
Participate in method verification, method transfer, and analytical method validation activities.
Coordinate with QA, Production, and Regulatory teams for sample analysis and timely release.

Required Skills
2–6 years of QC experience in the pharmaceutical industry (API/Formulation).
Hands-on experience with HPLC, GC, UV, Dissolution, KF, pH Meter, and analytical balances.
Knowledge of ICH Guidelines, cGMP, GLP, GDP, ALCOA+, OOS, OOT, and CAPA.
Experience with chromatography software such as Empower, Chromeleon, or LabSolutions.
Solid analytical, documentation, troubleshooting, and communication skills.

📌 Quality Control Officer Naidupeta
🏢 The Pharma Patashala
📍 Naidupeta