Manager API Manufacturing

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.
• Ensure adherence to valida...