Equipment Setup & Operation:Set up, calibrate, and operate core granulation machinery, including Rapid Mixer Granulators (RMG), Fluid Bed Dryers (FBD), Multi-Mills, and Vibro Sifters.
Batch Processing:Execute wet or dry granulation processes strictly following Batch Manufacturing Records (BMR), Batch Production Records (BPR), and Standard Operating Procedures (SOPs).
Material Handling & Blending: Verify, weigh, load, and premix raw materials and binders into granulators according to exact formulation ratios.
In-Process Quality Checks:Monitor process variables (such as binder spray rate, drying temperatures, moisture content, and loss-on-drying) and perform particle size distribution checks to ensure granule uniformity.
Line Clearance:Perform rigorous line clearance procedures before and after every batch to prevent cross-contamination between different product lines.
Regulatory Compliance:Adhere to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and Environmental Health and Safety (EHS) guidelines at all times.
Batch Documentation:Maintain detailed, real-time logbooks, equipment status tags, and BMR entry records to ensure total batch traceability.
Equipment Cleaning & Sanitization:Wash, sanitize, and assemble all product contact parts, tanks, and processing suites according to strict hygiene standards.
Troubleshooting & Maintenance:Identify operational abnormalities, assist with routine equipment maintenance, and report any process deviations immediately to quality control and supervisors.
