QC Officer - HPLC

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