Product Quality Specialist

1 week ago

Nelamangala, Karnataka, India beBeeAnalytical Full time ₹ 7,50,000 - ₹ 15,00,000
Product Quality Specialist

We seek an experienced Product Quality Specialist to join our team. This individual will be responsible for ensuring the quality of our products by conducting analytical testing and maintaining accurate records.

  • Key Responsibilities:
    • Perform routine and non-routine analysis using High Performance Liquid Chromatography (HPLC) for assay, dissolution, related substances, and stability studies
    • Prepare, review, and maintain test data, analytical records, and reports in compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
    • Calibrate, operate, and troubleshoot HPLC and other analytical instruments
    • Conduct testing of raw materials, intermediates, and finished formulations as per pharmacopeial and internal specifications
    • Assist in method validation and transfer activities
    • Investigate and document Out-of-Specification (OOS)/Out-of-Trend (OOT) results and deviations

Maintain proper documentation and data integrity in line with audit expectations.

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