API Production Operations Manager

1. Purpose of the Role

To plan, direct, and control API production operations to achieve targeted output, quality, cost efficiency, and regulatory compliance while ensuring safe, GMP-compliant, and environmentally responsible manufacturing.

2. Key Responsibilities

A. Production Planning & Operations

• Plan, execute, and monitor day-to-day API manufacturing activities as per approved production schedules.
• Ensure optimum utilization of men, machinery, materials, and utilities.
• Achieve production targets with minimal downtime and wastage.
• Coordinate with Planning, QC, QA, Engineering, and Stores for uninterrupted production flow.

B. GMP & Regulatory Compliance

• Ensure compliance with cGMP, WHO-GMP, USFDA, EU-GMP, and other regulatory standards.
• Implement and maintain SOPs, BMRs, logbooks, and manufacturing documentation.