Quality Control Analyst

HPLC Analyst – Job Responsibilities (Pharmaceutical Industry) Position: HPLC Analyst Department: Quality Control (QC) Key Responsibilities Perform analysis of raw materials, in-process samples, finished products, stability samples, and cleaning validation samples using HPLC and other analytical instruments. Operate, calibrate, maintain, and troubleshoot HPLC systems from leading manufacturers such as Shimadzu Corporation Conduct assay, dissolution, related substances, impurity profiling, content uniformity, and method verification testing as per approved specifications. Prepare mobile phases, diluents, standard and sample solutions as per analytical procedures.

Review chromatograms and ensure data integrity compliance (ALCOA+ principles). Maintain analytical records, laboratory notebooks, instrument logbooks, and test reports in compliance with cGMP and GLP requirements. Perform system suitability testing and ensure instruments are functioning within specified limits before analysis.

Participate in OOS (Out of Specification), OOT (Out of Trend), deviation, and laboratory investigation activities. Support analytical method validation, verification, transfer, and stability studies. Coordinate with QA and Production departments for timely sample testing and release activities.

Ensure adherence to SOPs, regulatory guidelines, and laboratory safety practices. Qualification B.Sc./M.Sc. (Chemistry), B.Pharm, or M.Pharm. Experience in handling Waters, Agilent, Shimadzu, or Thermo HPLC systems in a pharmaceutical QC laboratory.

Key Skills HPLC/UPLC Operation & Troubleshooting Chromatographic Analysis Dissolution Testing Method Validation & Transfer cGMP / GLP Compliance Data Integrity (ALCOA+) OOS/OOT Investigation Documentation & Regulatory Compliance Share resume at [email protected] or WhatsApp at 8929700006