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.
