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.