To perform and monitor granulation activities in solid oral dosage (OSD) manufacturing while ensuring compliance with cGMP, safety, and quality standards.
Key Responsibilities
⚙️ Production / Operation
- Operate granulation equipment such as RMG, FBD/FBE, blender, etc.
- Execute wet / dry granulation processes as per BMR (Batch Manufacturing Record)
- Set machine parameters and adjust during processing
- Perform equipment cleaning and line clearance
Monitoring & Control
- Monitor critical process parameters (temperature, time, RPM, etc.)
- Ensure in-process checks and report deviations
- Maintain batch records and logbooks accurately
Documentation
- Fill BMR/BPR entries in real-time
- Maintain equipment usage logs and cleaning records
- Follow SOPs and ensure proper documentation compliance
GMP & Safety Compliance
- Follow cGMP, GDP, and safety guidelines strictly
- Maintain cleanliness of granulation area
- Use PPE and ensure secure handling of materials
Coordination
- Coordinate with QA/IPQA for line clearance and sampling
- Work with maintenance team for breakdown handling
- Support shift supervisor in production activities
Required Skills
- Knowledge of granulation process (RMG, FBD, milling, blending)
- Understanding of cGMP & regulatory compliance (USFDA environment preferred)
- Basic knowledge of machine operation & troubleshooting
- Good documentation practices (GDP)
- Attention to detail & problem-solving skills
Qualification
- 10th / 12th + ITI / Diploma / D.Pharm
- Experience: 2–6 years in OSD manufacturing (granulation area preferred)
Key Equipment Exposure
- Rapid Mixer Granulator (RMG)
- Fluid Bed Dryer (FBD) / Fluid Bed Processor (FBP)
- Multi Mill / Co-mill
- Blender