Quality Control Executive

SAIN MEDICAMENTS PVT. LTD; Uppal; On-site; INR 350,000 - 500,000; Full time

Job summary

SAIN MEDICAMENTS PVT. LTD in Hyderabad seeks a QC Executive with 2–3 years of hands-on pharmaceutical QC experience, focusing on HPLC analysis. You will perform routine analysis of raw materials, in-process and finished products per approved specs, STPs and SOPs.

You will operate and troubleshoot HPLC systems, ensure system suitability, and maintain records while adhering to GMP/GLP and data integrity standards. Collaboration with QA, Production and other QC sections is essential.

Qualifications

• 2–3 years of hands-on experience in pharmaceutical QC.
• Strong experience in HPLC analysis and operation.
• Knowledge of GMP/GLP and data integrity principles.
• Familiarity with OOS/OOT investigations and laboratory deviations.

Responsibilities

• Perform HPLC analysis of samples as per approved specifications.
• Operate, maintain and troubleshoot HPLC instruments and related equipment.
• Carry out system suitability tests and ensure acceptance criteria.
• Prepare mobile phases, diluents and sample solutions accurately.
• Record data in worksheets, logs and reports with proper documentation.
• Assist in method validation, verification and transfer when required.

Skills

HPLC analysis

HPLC operation

GMP/GLP

Data integrity

OOS/OOT investigations

Documentation

Method validation / verification

Education

B.Pharm / M.Pharm / B.Sc / M.Sc in chemistry

Tools

Empower

Job description

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.