Quality Control Executive

QC EXECUTIVE – HPLC

Department: Quality Control (QC)

Designation: QC Executive

Experience: 2–3 Years

Industry: Pharmaceutical Formulations

Location: Hyderabad

Job Summary

We are looking for a QC Executive with 2–3 years of experience in pharmaceutical Quality Control, with strong hands-on experience in HPLC analysis. The candidate will be responsible for performing routine analysis of raw materials, in-process samples, finished products, stability samples and other pharmaceutical samples as per approved specifications, STPs and SOPs.

Key Roles & Responsibilities

• Perform HPLC analysis of pharmaceutical samples as per approved specifications, STPs and SOPs.
• Carry out analysis of raw materials, packing materials, in-process samples, finished products and stability samples.
• Operate, maintain and troubleshoot HPLC instruments and associated equipment.
• Perform system suitability tests and ensure chromatographic parameters meet acceptance criteria.
• Prepare mobile phases, diluents, standard solutions and sample solutions accurately.
• Perform standard and sample preparation as per analytical procedures.
• Review chromatograms and verify parameters such as retention time, area, resolution, theoretical plates, tailing factor and %RSD.
• Perform assay, related substances/impurities and other chromatographic tests as per approved methods.
• Maintain proper documentation of analytical results, observations and instrument usage.
• Record analytical data accurately in laboratory worksheets, logbooks and analytical reports.
• Handle OOS, OOT and analytical discrepancies in accordance with established procedures.
• Assist in method validation, method verification, method transfer and analytical method development, wherever required.
• Perform routine calibration and verification of laboratory instruments as per schedule.
• Ensure proper cleaning, operation and maintenance of HPLC instruments and laboratory equipment.
• Follow GMP, GLP, SOPs and data integrity requirements during all laboratory activities.
• Maintain good housekeeping and safety practices within the QC laboratory.
• Coordinate with QA, Production and other QC sections for timely completion of analysis and release activities.
• Ensure analytical records are complete, accurate and readily traceable during internal, customer and regulatory audits.
• Participate in investigations, CAPA implementation and laboratory-related compliance activities when required.
• Ensure timely completion of assigned samples and maintain laboratory turnaround time.

Technical Skills Required

• Strong hands-on experience in HPLC analysis.
• Knowledge of HPLC operation, troubleshooting and basic maintenance.
• Good understanding of chromatographic parameters and system suitability.
• Experience with Empower or other HPLC data acquisition systems is preferred.
• Knowledge of assay, related substances and dissolution-related analytical testing is an advantage.
• Good understanding of GMP, GLP, SOPs and data integrity principles.
• Basic knowledge of OOS/OOT investigations and laboratory deviations.
• Good documentation and analytical data-review skills.

Educational Qualification

B.Pharm / M.Pharm / B.Sc / M.Sc in Chemistry, Pharmaceutical Chemistry or a relevant discipline.

Experience

2–3 years of relevant experience in Pharmaceutical QC, preferably with substantial hands-on exposure to HPLC analysis in a formulations environment.