Officer/Senior Officer - Granulation

Role & responsibilities

Equipment Operation: Operate core granulation machinery, including Rapid Mixer Granulators (RMG), Fluid Bed Dryers (FBD), Roll Compactors, and Blenders.

1. Batch Execution: Convert fine powders into granules strictly following Batch Manufacturing Records (BMR) and Standard Operating Procedures (SOPs).
2. Parameter Monitoring: Monitor critical process parameters such as impeller/chopper speeds, binder spray rates, inlet/outlet air temperatures, and compaction force.
3. In-Process Quality Checks (IPQC): Conduct routine quality tests, including Loss on Drying (LOD) for moisture content, sieve analysis for particle size distribution, and bulk density testing.
4. cGMP & GDP Compliance: Document all processing steps in real time in batch records and logbooks, adhering to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
5. Equipment Cleaning & Line Clearance: Perform Clean-in-Place (CIP) procedures, equipment washdowns, and swab sampling between batches to prevent cross-contamination.
6. Environmental Control: Monitor cleanroom area conditions, ensuring room differential pressures, temperature, and relative humidity remain within validated limits.
7. Deviation Reporting: Identify and immediately report equipment malfunctions, process deviations, or Out-of-Specification (OOS) test results to Quality Assurance (QA).
8. Material Reconciliation & Yield: Track raw material inputs and output granule weights to calculate batch yield and account for material losses.
9. Audit Preparedness & Safety: Maintain constant area readiness for regulatory inspections (e.g., USFDA, MHRA, WHO) while strictly enforcing plant safety protocols and PPE requirements.