HPLC Analyst – Job Description

Job Title: HPLC Analyst / HPLC Operator / Quality Control Analyst

Department: Quality Control (QC) / Quality Assurance (QA)

Job Summary:

An HPLC Analyst is responsible for performing analytical testing of raw materials, in-process samples, finished products, and stability samples using High-Performance Liquid Chromatography (HPLC) instruments to ensure product quality and compliance with regulatory standards such as GMP, GLP, and SOPs.

Key Roles and Responsibilities
Operate, calibrate, and maintain HPLC instruments.
Perform routine analysis of raw materials, in-process samples, and finished products.
Prepare mobile phases, buffer solutions, and standard/sample solutions.
Perform HPLC analysis as per approved analytical methods and SOPs.
Handle instruments such as HPLC, UV-Visible Spectrophotometer, and other analytical equipment.
Perform system suitability tests before sample analysis.
Calculate assay, impurities, related substances, and dissolution results.
Maintain instrument logbooks and analytical records.
Perform instrument calibration and routine troubleshooting.
Follow GMP, GLP, data integrity,



and laboratory safety guidelines.
Prepare and maintain analytical worksheets and test reports.
Investigate OOS (Out of Specification) and OOT (Out of Trend) results under approved procedures.
Maintain proper documentation as per regulatory requirements.
Ensure cleanliness and proper maintenance of laboratory equipment.

Required Technical Skills
HPLC operation and troubleshooting.
Knowledge of HPLC columns, pumps, detectors, and injectors.
Mobile phase and sample preparation.
Knowledge of chromatographic techniques.
Understanding of assay, impurities, and related substances.
Knowledge of GMP, GLP, and SOPs.
Basic knowledge of Empower, ChemStation, or Chromeleon software.

Educational Qualification
B.Sc. / M.Sc. in Chemistry.
B.Pharm / M.Pharm.
Diploma or degree in a relevant scientific field.

Experience
Fresher or 1–3 years of experience in the pharmaceutical QC laboratory.
Experience in HPLC analysis is preferred.

Pay: ₹20,000.00 - ₹30,000.00 per month

Perks:
Provident Fund

Work Location: In person

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