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.