Roles & Responsibilities

• To plan and execute Biochemical & Physicochemical assays for batch release and stability with in defined TAT
• Physicochemical assays like protein estimation, moisture content, pH, Physical appearance, Sub-visible particle measurement, Reconstitution of lyophilized vails, extractable volume, general description etc.
• To perform periodical calibration and maintenance of analytical instruments as per schedule.
• Conduct breakdown analysis, improve preventive maintenance, and collaborate with cross-functional teams to resolve discrepancies and implement corrective actions.
• Ensure compliance with GMP, safety standards, and SOPs, maintain audit readiness, and manage QMS elements including documentation, CAPA closure, and training