Production Operator

Position Summary.

Formulation Operator is responsible for carrying out manufacturing activities related to oral solid dosage (OSD) forms, including granulation, compression, and coating operations. The role ensures all processes are executed in compliance with GMP, SOPs, and safety guidelines while achieving required production targets and product quality standards.

Key Responsibilities.

1. Granulation

Operate and monitor granulation equipment (RMG, FBD, Blenders, Sifters).

Perform material charging, mixing, wet granulation, drying, and sizing activities.

Ensure granulation parameters are followed as per BMR/BPR.

Conduct in-process checks such as LOD, bulk density, particle size, and granule uniformity.

Maintain cleanliness of granulation area and equipment.

2. Compression

Set up, operate, and troubleshoot tablet compression machines.

Perform machine changeover, tooling installation, and parameter adjustments.

Carry out in-process quality checks (weight variation, thickness, hardness, friability).

Monitor tablet defects and take corrective actions.

Ensure die and punch handling as per SOP to prevent damage or contamination.

3. Coating

Operate coating machines (auto coater/equipment).

Prepare coating solutions/suspensions as per approved instructions.

Monitor critical coating parameters (spray rate, inlet/outlet temp, pan speed).

Conduct IPC tests for coating uniformity, weight gain, and appearance.

Handle cleaning and line clearance.

Documentation & Compliance

Complete BMR/BPR and logbook entries accurately and on time.

Follow cGMP, GDP, and safety protocols strictly.

Participate in line clearance, deviation reporting, and CAPA implementation.

Ensure adherence to SOPs, safety guidelines, and production schedules.

Equipment Handling & Maintenance

Perform basic machine troubleshooting and coordinate with maintenance for repairs.

Ensure calibration and proper functioning of weighing balances and critical instruments.

Maintain 5S and hygiene standards in the work area.