Role & responsibilities

Job Purpose The Assistant Manager Granulation will be responsible for leading, coordinating, and managing the daily shop floor operations within the Granulation section of a regulated Oral Solid Dosage (OSD) manufacturing plant. This role ensures that all batch manufacturing activities comply strictly with cGMP, standard operating procedures (SOPs), and international regulatory requirements (such as USFDA, MHRA, and EU-GMP), while achieving targeted production volumes safely and efficiently.

Key Responsibilities

1. Production Planning & Shop Floor Execution

- Lead and monitor daily operations of the Granulation department, including High Shear Mixers (RMG), Fluid Bed Dryers (FBD), Blenders, Sifters, and Milling systems.
- Execute production schedules to meet volume targets, ensuring optimum machine utilization, efficient manpower deployment, and minimum downtime.
- Oversee critical granulation processes like wet granulation, dry granulation (roller compaction), direct blending, and fluid bed processing.
- Ensure strict Line Clearance protocols are executed before initiating any manufacturing step.

2. cGMP & Quality Compliance

- Ensure total adherence to Current Good Manufacturing Practices (cGMP), internal Quality systems, and safety compliance policies on the floor.
- Review and verify Batch Manufacturing Records (BMR), logbooks, and equipment cleaning records online to guarantee accuracy and prompt closure.
- Participate actively in investigation processes for deviations, Out of Specifications (OOS), and implement robust Corrective and Preventive Actions (CAPA).




- Act as a core member during internal audits and international regulatory inspections (USFDA, MHRA, WHO, etc.).

3. Equipment & Process Maintenance

- Supervise the qualification, validation, calibration, and proactive maintenance schedules of all granulation machinery in coordination with the Engineering team.
- Drive troubleshooting strategies during batch failures, processing difficulties, or equipment breakdowns to prevent interruptions.
- Support technical transfer, scale-up operations, and process validation trials for new formulations arriving from R&D.;

4. Team Leadership & Resource Management

- Manage, mentor, and build a capable team of shift executives, supervisors, and operators.
- Map training matrices and systematically execute training programs covering SOP updates, safety protocols, and operational skills.
- Promote a continuous improvement mindset utilizing Lean Six Sigma tools to minimize waste and optimize material yields.

Required Qualifications & Competencies

- Educational Background: B. Pharm / M. Pharm or Master’s degree in a relevant scientific stream.
- Experience Range: 10 to 15 years of hands-on experience in OSD Manufacturing, with at least 5 years explicitly focused on Granulation lines within a regulatory-approved plant.
- Technical Knowledge: Deep understanding of modern granulation equipment automation (PLC/SCADA operations), Quality Management Systems (QMS), and process optimization protocols.
- Soft Skills: Solid cross-functional coordination abilities (with QA, QC, Warehouse, and Maintenance), analytical problem-solving skills, and a proven track record of handling shift operations independently.

📌 Assistant Manager - Production (Granulation) (Mumbai)
🏢 Rubicon Research
📍 Mumbai