- 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), Valuable 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.