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.
Deputy General Manager • Indore, Madhya Pradesh, India