Job Summary
The General Manager – Operations is responsible for leading end-to-end API manufacturing operations, ensuring safe, compliant, and cost-effective production while meeting quality, delivery, and business objectives. The role oversees production, engineering, maintenance, EHS, quality coordination, and continuous improvement initiatives in compliance with cGMP and regulatory requirements.
Key Responsibilities
Manufacturing Operations
Lead API production to achieve production targets.
Ensure optimum utilization of manpower, equipment, and utilities.
Improve productivity, yield, and overall equipment effectiveness (OEE).
Minimize downtime and production losses.
Regulatory & GMP Compliance
Ensure compliance with cGMP, ICH, US FDA, EU GMP, WHO GMP, and applicable regulatory standards.
Support customer and regulatory audits.
Ensure accurate documentation and data integrity practices.
Cost & Budget Management
Control manufacturing costs.
Reduce waste and improve process efficiency.
Prepare and monitor operational budgets.
Identify cost-saving opportunities.
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