To operate and monitor granulation equipment and processes in compliance with cGMP, SOPs, and safety standards, ensuring consistent production of high-quality pharmaceutical granules for tablet or capsule formulation.
Key Responsibilities
- Operate granulation equipment such as high-shear mixers, fluid bed dryers, oscillating mills, and blenders.
- Weigh, dispense, and mix raw materials as per batch manufacturing records (BMR).
- Monitor granulation parameters and adjust settings to maintain product quality.
- Perform in-process checks (e.g., moisture content, granule size) and document results accurately.
- Clean and maintain equipment and work areas as per SOPs.
- Execute machine changeovers and line clearance activities.
- Identify and report deviations or equipment malfunctions to the supervisor.
- Ensure compliance with cGMP, safety, and environmental regulations.
- Participate in continuous improvement and troubleshooting initiatives.
Qualifications
- ITI / Diploma / B.Sc or equivalent; technical diploma preferred.
- 46 years of experience in pharmaceutical manufacturing, preferably in granulation.
- Familiarity with cGMP, USFDA guidelines, and pharmaceutical documentation practices.
- Ability to read and interpret batch records and SOPs.
- Basic computer skills and understanding of production documentation.
Preferred Skills
- Attention to detail and strong documentation habits.
- Mechanical aptitude for operating and troubleshooting equipment.
- Team player with good communication skills.
- Forklift certification (if required for material handling).
