About this role
- xecute granulation activities as per approved BMR, SOPs, and manufacturing instructions . Operate and monitor granulation equipment such as: Rapid Mixer Granulator (RMG) Fluid Bed Dryer (FBD) Multi Mill / Co-Mill Sifter Octagonal Blender / Conta Blender Other associated granulation equipment.
- Perform equipment and area line clearance before starting manufacturing activities.
- Verify equipment cleanliness and equipment status before use.
- Charge raw materials into equipment as per approved manufacturing sequence and quantities.
- Operate RMG and monitor critical parameters such as: Impeller speed Chopper speed Mixing time Binder addition Granulation endpoint Operate FBD and monitor parameters such as: Inlet temperature Product temperature Airflow Drying time LOD/moisture level Operate milling and sifting equipment as per approved specifications.
- Ensure proper transfer and collection of dried and milled granules.
- Perform blending activities as per approved BMR and SOP.
- Monitor granule appearance, moisture, particle size, and other applicable in-process parameters.
- B. Process Monitoring & Troubleshooting Monitor the granulation process and immediately report abnormalities to the Production Officer/Supervisor.
- Identify common granulation issues such as: Over-wetting Under-granulation Over-granulation Improper drying High/low LOD Improper particle size Equipment-related abnormalities Assist in troubleshooting process and equipment-related issues.
- Ensure process parameters remain within approved limits.
- Minimize material loss and prevent cross-contamination during manufacturing.
- C. GMP & Documentation Follow cGMP, SOPs, GDP, and data integrity requirements at all times.
- Record process parameters and activities accurately and contemporaneously in the BMR and equipment logbooks.
- Complete equipment usage, cleaning, and operation records.
- Follow approved procedures for material identification, status verification, and reconciliation.
- Report deviations, incidents, breakdowns, and abnormal observations immediately.
- Maintain proper documentation of yield, material consumption, and process activities.
- Support investigations related to deviations, process failures, and manufacturing issues.
- D. Equipment Cleaning & Area Management Perform cleaning of granulation equipment and manufacturing areas as per approved SOPs.
- Ensure proper dismantling, cleaning, drying, and assembly of equipment where applicable.
- Verify equipment cleanliness before and after batch operations.
- Maintain equipment status labels and cleaning status.
- Ensure proper handling of product-contact parts.
- Maintain good housekeeping and 5S practices in the granulation area.
- E. Material Handling Handle raw materials and in-process materials carefully according to SOPs.
- Verify material name, batch number, quantity, and status before use.
- Ensure correct material charging sequence as specified in the BMR.
- Prevent material mix-up and cross-contamination.
- Ensure proper identification and labelling of containers and intermediate materials.
- Assist in material reconciliation and yield calculation.
- F. Safety Follow all EHS and occupational safety procedures . Wear appropriate PPE during manufacturing and cleaning activities.
- Follow safe operating procedures for RMG, FBD, Multi Mill, Sifter, and other equipment.
- Handle powders and cleaning agents safely.
- Report unsafe conditions, accidents, near misses, and equipment hazards immediately.
- Maintain proper housekeeping to prevent slip, trip, dust, and other workplace hazards.
- G. Coordination & Teamwork Coordinate with Production Officers, IPQA, Warehouse, Engineering, and other relevant departments for smooth batch execution.
- Follow instructions from the Production Officer/Supervisor.
- Support timely completion of manufacturing activities according to the production plan.
- Participate in shift handover and communicate batch/process status clearly.
- Assist in training and guiding new operators on equipment operation and GMP practices.
- 4. Key Performance Indicators (KPIs) Timely completion of granulation batches.
- Batch yield and reduction in process losses.
- Compliance with BMR/SOP/GMP requirements.
- Accuracy and completeness of documentation.
- Granulation process efficiency.
- Equipment utilization and reduction in downtime.
- Reduction in process deviations and recurring issues.
- Cleaning and line-clearance compliance.
- Safety and housekeeping performance.