Role & responsibilities

Purpose

To lead, manage, and optimize daily operations within the Compression and Coating sections of a regulated Oral Solid Dosage (OSD) manufacturing unit. This role ensures full compliance with cGMP norms, manages a 20-member shift workforce, and successfully defends equipment and processing workflows during international regulatory audits.

Responsibilities

- Lead and manage a dedicated production team of approx. 20 members, including shift executives, supervisors, and operators.
- Plan, monitor, and execute daily operations involving high-speed compression machines, auto-coaters, weight-sorting machines, and de-dusters.
- Oversee critical manufacturing activities like bilayer compression, tool management, film coating, functional coating, and sugar coating.
- Ensure strict Line Clearance protocols, parameter monitoring, and machine sanitization procedures are meticulously followed.
- 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 compression and coating section workflows.
- Participate actively in Quality Management System (QMS) activities, investigating floor deviations, non-conformances, and implementing effective CAPAs.
- Supervise the qualification, validation, calibration, and maintenance of compression tooling and coating systems 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 a perpetual state of audit readiness.




- Map training matrices and execute systematic technical, cGMP, and safety training programs for the entire 20-member team.
- Implement continuous improvement initiatives to minimize weight variation, reduce coating defects (like chipping or peeling), and optimize yield.

Required Skills

- Compression & Coating Tech: Deep operational knowledge of modern, automated processing machinery (PLC/SCADA-driven Fette, Korsch, Cadmach, Sejong, and auto-coaters).
- Workforce Management: Proven ability to direct, motivate, and manage a technical shift team of 20+ personnel.
- Audit Front-Facing: Solid capability and confidence to face and defend mechanical setups and processing data during strict USFDA and MHRA inspections.
- Tooling & Troubleshooting: Proficient in executing root cause analysis for physical tablet defects (capping, sticking, twinning) and handling QMS deviations.
- Technical Documentation: Excellent online documentation habits along with the verbal communication skills required for 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 shop floor team of at least 15 to 20 people simultaneously.
- Audit Track Record: Demonstrated history of successfully defending compression and coating block operations during recent USFDA / MHRA / global regulatory audits.
- Operational Flexibility: Total readiness to work in all rotational shifts and handle intense corporate production delivery schedules.

📌 Assistant Manager - OSD Production (Compression & Coating) - Pithampur
🏢 Rubicon Research
📍 Pithampur