About the role
Batch Production Execution: Execute daily granulation batches according to standard operating procedures (SOPs) and Batch Manufacturing Records (BMR). Equipment Operation: Operate specialized processing machinery, including Rapid Mixer Granulators (RMG), Fluid Bed Dryers (FBD), Roll Compactors, Multi-Mills, and Vibro Sifters. Process Parameter Monitoring: Monitor critical parameters such as mixing time, binder spray rates, drying temperatures, moisture content, and granule size distribution. In-Process Quality Checks: Perform regular checks (e.g., loss on drying [LOD], bulk density, particle size analysis) to ensure products meet stringent quality specifications. cGMP Compliance: Maintain strict compliance with current Good Manufacturing Practices (cGMP), hygiene protocols, and environmental health and safety (EHS) guidelines. Batch Documentation: Accurately complete batch documentation, logbooks, and yield calculations following Good Documentation Practices (GDP). Cleanroom & Equipment Maintenance: Ensure proper cleaning, sanitation, and line clearance of granulation suites and machinery to prevent cross-contamination between batches. Troubleshooting & Optimization: Identify equipment malfunctions or process deviations early and coordinate with maintenance or Quality Assurance (QA) teams for swift resolution. Raw Material Handling: Verify and handle active pharmaceutical ingredients (APIs) and excipients according to exact formulation cards. Team & Audit Support: Assist in internal/external regulatory audits and collaborate with QA, QC, and downstream compression/encapsulation teams to maintain steady production flow.