Head - MSAT ( Solid Orals)

Key Responsibilities
Technical Operations & Process Excellence
Lead scale-up, engineering batches, PPQ batches, process validation, and technology transfer activities.
Review and approve validation protocols, reports, and batch manufacturing records.
Drive process optimization, troubleshooting, revalidation, batch size changes, equipment changes, and alternate vendor development.
Act as SME for process-related deviations, OOS, CAPA, change controls, and investigations.
Ensure effective risk assessments and continuous process improvement initiatives.
Support facility and equipment qualification activities.
Manufacturing Network Strategy & Planning
Lead capacity planning and RCCP activities to align demand with manufacturing capabilities.
Identify manufacturing constraints and implement mitigation plans.
Review forecasts, production schedules, and site commitments to ensure timely product supply.
Drive production scheduling, resource utilization, and s...

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