QC Officer- HPLC Analyst

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.

How to Apply

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

[email protected]

[email protected]