Job Description

We are looking for a

QC Officer - HPLC

with pharmaceutical industry experience to perform chromatographic analysis of raw materials, in-process, finished products, and stability samples in compliance with

cGMP and regulatory guidelines

.

Key Responsibilities :

1. HPLC & Analytical Testing

Perform routine analysis using

HPLC

for assay, related substances, dissolution, and content uniformity Analyze

API, excipients, intermediates, and finished dosage forms

Operate and troubleshoot HPLC systems (Agilent, Waters, Shimadzu, etc.)

2. Method & Documentation

Follow

pharmacopoeial and in-house validated methods

(USP, EP, IP, BP) Prepare and review

chromatograms, worksheets, and COAs

Maintain complete documentation as per

GDP and ALCOA+

principles

3. Compliance & Investigations

Ensure compliance with

cGMP, GLP, and data integrity

Participate in

OOS, OOT, deviations, and CAPA

investigations Support internal, customer, and regulatory audits (USFDA, WHO, MHRA)

4. Equipment & Maintenance

Perform

calibration, qualification, and preventive maintenance

of HPLC instruments Maintain instrument logs, column usage logs, and solvent records

5. Stability & Validation

Conduct

stability testing

as per ICH guidelines Assist in

method validation, verification, and method transfer

Required Skills & Knowledge :

Strong hands-on experience with

HPLC in pharma QC labs

Sound knowledge of

ICH guidelines, GMP, and pharmacopoeial standards

Experience in handling

regulated documentation

Good understanding of

data integrity and audit readiness

Job Types: Full-time, Permanent

Benefits:

Food provided Leave encashment Provident Fund
Work Location: In person