Officer/Senior Officer - Granulation

USV; Poicha; On-site; INR 450,000 - 650,000; Full time

Job summary

USV in Gujarat, Poicha invites applications for a role operating granulation processes and ensuring GMP/GDP compliance. Responsibilities include batch execution, IPQC tests, CIP and line clearance, environmental control, deviation reporting, material yield tracking, and audit readiness.

The position emphasizes strict adherence to BMR/SOPs, robust QA collaboration, and maintaining safety standards in a cGMP environment.

Responsibilities

• Batch Execution: Convert fine powders into granules strictly following Batch Manufacturing Records (BMR) and SOPs.
• Parameter Monitoring: Monitor impeller/chopper speeds, binder spray rates, inlet/outlet air temperatures, and compaction force.
• IPQC: Conduct Loss on Drying (LOD), sieve analysis, and bulk density testing.
• cGMP & GDP: Document processing steps in batch records and logbooks per cGMP and GDP.
• Cleaning & Line Clearance: Perform CIP, washdowns, and swab sampling between batches to prevent cross-contamination.
• Environmental Control: Monitor cleanroom conditions—diff pressures, temp, RH within validated limits.
• Deviation Reporting: Report malfunctions, deviations, or OOS results to QA.
• Material Reconciliation & Yield: Track material inputs/outputs to calculate batch yield.
• Audit Preparedness & Safety: Maintain area readiness for regulatory inspections and PPE compliance.

Skills

RMG operation

FBD operation

Roll compactor operation

Blender operation

Batch execution

IPQC

cGMP & GDP compliance

Clean-in-Place

Line clearance

Job description

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.