Deputy General Manager (DGM) / Assistant General Manager (AGM) - Downstream Production (API)

Key Responsibilities : Operational Leadership :

Lead and oversee all downstream API production activities including filtration, centrifugation, drying, milling, sifting, and packing .

Ensure adherence to production targets , quality standards , and delivery timelines .

Drive continuous improvement in yield, throughput, and efficiency while minimizing waste and downtime.

Compliance & Documentation :

Ensure cGMP , FDA , WHO , and other regulatory compliance in downstream operations.

Review and approve Batch Manufacturing Records (BMRs) , SOPs , and Change Controls related to downstream processes.

Lead and support regulatory audits (USFDA, EU, TGA, etc.) and internal quality inspections.

Team Management :

Manage and mentor a team of shift managers, supervisors, operators , and technical staff.

Conduct performance reviews , skill development , and ensure a culture of safety and accountability .

Process Improvement & Technology :

Collaborate with Process Engineering, R&D, and QA to implement process optimizations and technology upgrades .

Drive initiatives such as QbD, PAT , and Lean Manufacturing in downstream operations.

Inventory & Cost Control :

Coordinate with SCM to ensure availability of consumables and utilities for uninterrupted operations.

Monitor and control production costs , material losses , and energy consumption .

Experience Required :

15+ Years in API Manufacturing.