Assistant Manager - OSD Production (Compression & Coating) - Pithampur

Rubicon Research; Pithampur; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Rubicon Research in India seeks an experienced Senior Production Lead for the Compression and Coating sections in an OSD manufacturing unit. You will manage a 20-member shift, ensure cGMP compliance, and defend processes during regulatory audits.

Responsibilities include planning daily operations with high-speed compression and coating lines, ensuring Line Clearances, maintaining BMRs, and coordinating with QA, QC, Warehouse, and Maintenance to hit weekly targets.

Qualifications

• Full-time B.Pharm, M.Pharm or MSc Chemistry degree from a recognized university.
• 10–15 years of core production experience in a regulatory-approved OSD plant.
• Experience leading a shop floor team of 15–20 people simultaneously.
• Demonstrated history defending compression and coating operations during USFDA/MHRA/global 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 bilayer compression, tool management, film/coating, functional coating and sugar coating activities.
• Ensure strict Line Clearance, parameter monitoring, and machine sanitization procedures.
• Review Batch Manufacturing Records, logbooks, and equipment cleaning records for real-time compliance.
• Front-face major international regulatory audits (USFDA, MHRA, EU-GMP, WHO) for all workflows.
• Participate in QMS activities, investigating deviations and implementing CAPAs.
• Supervise qualification, validation, calibration, and maintenance of tooling and coating systems with Engineering.
• Coordinate with QA, QC, Warehouse, and Maintenance to hit weekly production targets.
• Draft and update SOPs to maintain audit readiness.
• Map training matrices and conduct cGMP and safety training for the 20-member team.
• Implement continuous improvement to minimize weight variation and coating defects, optimize yield.

Skills

Compression & Coating

Workforce Management

Audit Front-Facing

Tooling & Troubleshooting

Technical Documentation

Education

B.Pharm, M.Pharm, M.Sc Chemistry

Tools

Fette

Korsch

Cadmach

Sejong

Auto-coaters

Job description

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: Strong 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.