Role & responsibilities

Purpose To lead, manage, and optimize daily operations within the Granulation section of a regulated Oral Solid Dosage (OSD) manufacturing unit. This role ensures full compliance with cGMP norms, manages a large workforce, and successfully defends production practices during international regulatory audits.

Responsibilities

- Lead and manage a large production team of approx. 40 members, including shift executives, supervisors, and operators.
- Plan, monitor, and execute daily granulation operations involving RMG, Fluid Bed Dryers (FBD), Blenders, Sifters, and Milling systems.
- Oversee critical manufacturing processes like wet granulation, dry granulation (roller compaction), and direct compression blending.
- Ensure strict Line Clearance protocols and machine sanitization procedures are strictly executed before batch processing.
- Review and verify Batch Manufacturing Records (BMR), logbooks, and equipment cleaning records online for real-time compliance.
- Front-face major international regulatory audits (USFDA, MHRA, EU-GMP, WHO) for all granulation section workflows.
- Participate actively in Quality Management System (QMS) activities, investigating floor deviations and implementing effective CAPAs.
- Supervise the qualification, validation, and calibration of granulation machinery in coordination with the Engineering team.
- Coordinate cross-functionally with QA, QC, Warehouse, and Maintenance teams to achieve weekly production targets.
- Draft, review, and update section-specific Standard Operating Procedures (SOPs) to ensure continuous audit readiness.




- Map training matrices and execute systematic technical and safety training programs for the entire 40-member team.
- Implement Lean Six Sigma or continuous improvement tools to reduce batch cycle time and minimize material waste on the floor.

Required Skills

- Granulation Technology Mastery: Deep operational knowledge of up-to-date, automated granulation equipment (PLC/SCADA-driven RMG, FBD, Roller Compactors).
- Large-Scale Leadership: Proven ability to direct, motivate, and manage a massive shift workforce of 40+ technical personnel.
- Audit Front-Facing: Strong capability and confidence to face and defend production practices during strict USFDA and MHRA inspections.
- QMS & Troubleshooting: Proficient in executing root cause analysis for processing failures and handling deviations or shop-floor incidents.
- Technical Communication: Excellent documentation habits along with the verbal skills required for cross-functional alignment and audit justification.

Preferred Candidate Details

- Education: Full-time B.Pharm , M.Pharm, M.Sc Chemistry degree from a recognized university.
- Experience Range: 10 to 15 years of core production experience exclusively within a regulatory-approved OSD manufacturing plant.
- Leadership Stature: Must have past experience managing a large-scale shop floor team of at least 30 to 40 people simultaneously.
- Audit Track Record: Demonstrated history of successfully defending granulation blocks during recent USFDA / MHRA / global regulatory audits.
- Operational Flexibility: Total readiness to work in all rotational shifts and handle intense corporate target delivery schedules.

📌 Assistant Manager - OSD Production (Granulation) - Pithampur (Indore)
🏢 Rubicon Research
📍 Pithampur