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.
- Valuable 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.

How to Apply

Interested candidates meeting the above criteria may apply with their updated resume.

[email protected] [email protected]

📌 QC Officer- HPLC Analyst (Pune)
🏢 Sterling Healthcare
📍 Pune