Key Responsibilities
1. Plant Operations Management
- Oversee daily manufacturing operations of API production units
- Ensure achievement of production targets with optimum resource utilization
- Monitor process efficiency, yields, and downtime reduction
- Implement continuous improvement
2. Regulatory & Compliance (cGMP)
- Ensure compliance with cGMP, USFDA, WHO, EDQM
- Lead audits (internal, external, regulatory)
- Maintain strong Quality Management Systems (QMS)
- Ensure proper documentation (BMR, BPR, SOPs)
3. Production & Process Optimization
- Improve batch cycle time, yield, and productivity
- Troubleshoot process deviations and failures
- Coordinate with R&D / Tech Transfer for scale-up activities
- Implement cost-saving initiatives without compromising quality
4. Cross-Functional Coordination
- Work closely with:
- Quality Assurance (QA)
- Quality Control (QC)
- Engineering & Maintenance
- Supply Chain & Warehouse
- Ensure smooth production planning & material availability
5. Safety, Health & Environment (EHS)
- Ensure plant safety and statutory compliance
- Implement zero-incident safety culture
- Monitor hazardous chemical handling & waste disposal
6. Financial & Cost Management
- Manage plant budget, cost control, and P&L aspects
- Optimize manpower, utilities, and raw material usage
- Drive profitability through operational efficiency
7. Team Leadership
- Lead and manage production teams, shift in-charges, and managers
- Develop manpower through training and performance management
- Build high-performance culture and accountability
8. Strategic Planning
- Develop long-term operational strategies
- Support capacity expansion and new projects
- Align plant operations with company growth plans