Analyst, Quality Control Development

Job purpose

The main responsibility for this position is to perform method development, validation and transfer activities to support quality control development department.

Duties and responsibilities

• Perform Assay and Related Substances method development and validation study using HPLC, GC and other instrumental techniques.
• Ensure timely completion of routine analysis for bulk, finished products, exhibit batches, and stability samples.
• Prepare protocol, test method and report related with method validation and method transfer studies.
• Conduct method verification, compendial update & method transfer activities.
• Identify and implement key process improvements to enhance systems, improve efficiency, and meet GMP requirements.
• Ensure Out-of-Specification (OOS), Out-of-Trend (OOT), and Corrective and Preventive Actions (CAPAs) are completed within defined timelines.
• Assist the Manager/Supe...