Senior Executive, Manufacturing Process Operations
Amneal Pharmaceuticals · India
Role Summary – Deputy Manager, Encapsulation (OSD)
The role is responsible for managing and optimizing OSD encapsulation operations to ensure consistent product quality, regulatory compliance, and achievement of production targets. The incumbent oversees capsule filling, equipment setup, in-process controls, line clearance, yield reconciliation, documentation, and cross-contamination controls in compliance with cGMP. The role also supports process validation, technology transfer, investigations, CAPA, productivity improvement, cost optimization, audit readiness, and effective team management.
Essential Responsibilities
- Manage day-to-day capsule manufacturing operations in compliance with cGMP, SOPs, and approved production plans.
- Oversee capsule-filling processes, equipment setup, in-process checks, line clearance, yield reconciliation, and documentation.
- Ensure achievement of production targets, optimum capacity utilization, process efficiency, and reduction of rejection and material loss.
- Monitor critical process parameters and ensure consistent product quality, process robustness, and prevention of cross-contamination.
- Coordinate equipment qualification, process validation, technology transfer, scale-up, and new-product introduction activities.
- Support deviation investigations, CAPA, change controls, risk assessments, and timely closure of audit observations.
- Coordinate with QA, QC, Engineering, Warehouse, Planning, and other functions for smooth manufacturing operations.
- Train and develop team members while ensuring discipline, compliance, and effective workforce deployment.
General Safety Responsibilities
- Ensure compliance with EHS procedures, statutory requirements, and safe operating practices.
- Ensure proper use of PPE, machine guards, safety interlocks, dust-extraction systems, and material-handling controls.
- Promote reporting of incidents, near misses, unsafe acts, and unsafe conditions.
- Participate in safety training, risk assessments, audits, and emergency-preparedness activities.
Required Skills
- Strong knowledge of capsule-filling processes, capsule-manufacturing equipment, and in-process controls.
- Sound understanding of cGMP, data integrity, validation, documentation, and regulatory requirements.
- Knowledge of troubleshooting, root-cause analysis, CAPA, process optimization, and yield improvement.
- Good team management, production planning, decision-making, and cross-functional coordination skills.
- Strong communication, analytical, problem-solving, and people-development abilities.