QC Officer- HPLC Analyst

Sterling Healthcare; Pune District; On-site; INR 650,000 - 900,000; Full time

Job summary

Sterling Healthcare is hiring a QC Officer HPLC Analyst for its Talegaon site in Pune. The role demands hands-on HPLC analysis, quality control testing for oral solid dosage products, and ensuring compliance with cGMP/GLP standards.

The candidate will handle method validation tasks and ensure thorough documentation, contributing to robust laboratory records and data integrity in a fast-paced pharmaceutical environment.

Qualifications

• Hands-on experience in HPLC analysis within a pharmaceutical QC laboratory.
• Knowledge of analytical testing of Oral Solid Dosage formulations.
• Understanding of assay, dissolution, related substances, and stability testing.
• Familiarity with cGMP, GLP, SOPs and data integrity requirements.

Responsibilities

• Perform HPLC analysis of raw materials, in-process samples and finished products.
• Conduct assay, dissolution, related substances, content uniformity and other tests.
• Prepare solutions, mobile phases and buffers per procedures.
• Operate, calibrate and troubleshoot HPLC systems and instruments.
• Review chromatograms and ensure accuracy of lab records.
• Maintain compliance with cGMP/GLP and ALCOA+ data integrity.
• Support method validation, verification, transfer and stability studies.
• Maintain instrument logs, calibration records and QC documentation.

Skills

HPLC analysis

Analytical testing knowledge

Documentation

Education

B.Pharm / M.Pharm / M.Sc. Chemistry

Job description

Job Title: QC Officer HPLC Analyst

Department: Quality Control (QC)
Industry: Pharmaceutical / Formulation Manufacturing
Job Function: Quality Control Analytical
Qualification: B.Pharm / M.Pharm / M.Sc. Chemistry
Experience: 15 Years
Employment Type: Full-Time
Job Location: Sterling Healthcare LTD Talegaon, Pune

Job Summary

We are hiring a QC Officer HPLC Analyst for our Oral Solid Dosage (OSD) Formulation Plant. The ideal candidate should have hands‑on experience in HPLC analysis, pharmaceutical formulation testing, analytical documentation, and compliance with cGMP and GLP requirements.

Key Responsibilities

• Perform HPLC analysis of raw materials, in-process samples, finished products, and stability samples.
• Conduct assay, dissolution, related substances, content uniformity, and other applicable analytical tests for tablets and capsules.
• Prepare standard solutions, sample solutions, mobile phases, and buffers as per approved procedures.
• Operate, calibrate, and troubleshoot HPLC systems and associated analytical instruments.
• Execute analytical testing as per approved Standard Test Procedures (STPs), specifications, and pharmacopoeial methods.
• Review chromatograms, calculate analytical results, and ensure accuracy and completeness of laboratory records.
• Maintain compliance with cGMP, GLP, ALCOA+ data integrity principles, and laboratory SOPs.
• Participate in Out of Specification (OOS), Out of Trend (OOT), deviation, and laboratory investigation activities.
• Support analytical method validation, method verification, method transfer, and stability studies, as applicable.
• Maintain instrument usage logbooks, calibration records, analytical worksheets, and other QC documentation.
• Ensure proper handling of laboratory chemicals, reference standards, reagents, and samples.
• Follow laboratory safety procedures and maintain good housekeeping practices.

Required Skills and Competencies

• Hands‑on experience in HPLC analysis within a pharmaceutical QC laboratory.
• Knowledge of analytical testing of Oral Solid Dosage (OSD) formulations.
• Understanding of assay, dissolution, related substances, and stability testing.
• Knowledge of cGMP, GLP, SOPs, and data integrity requirements.
• Familiarity with IP, USP, BP, and other applicable pharmacopoeial standards.
• Ability to interpret chromatograms, perform analytical calculations, and troubleshoot basic HPLC issues.
• Good documentation, analytical, and problem‑solving skills.

Educational Qualification

B.Pharm / M.Pharm / M.Sc. Chemistry or an equivalent relevant qualification.

Preferred Candidate Profile

Candidates with relevant experience in Quality Control HPLC Analysis at a pharmaceutical formulation manufacturing plant, preferably in tablets and capsules, will be preferred.