Role Summary
The Production Manager will be responsible for leading and managing all day-to-day
manufacturing activities within the Active Pharmaceutical Ingredient (API) unit. The
role ensures efficient, cost-effective, and quality-compliant production in line with Good
Manufacturing Practices (GMP) and regulatory standards, meeting defined production
...
schedules and targets.
Key Responsibilities
1. Manufacturing Operations & Efficiency.
- Production Planning: Implement and execute the daily, weekly, and monthly production schedules for various API products to meet delivery timelines.
- Process Management: Oversee all unit operations, including reaction, filtration, distillation, drying, and packing, ensuring processes are executed as per approved Batch Production Records (BPRs).
- Yield & Cycle Time: Continuously monitor and analyze key performance indicators (KPIs) such as yield, batch cycle time, and capacity utilization to drive operational efficiency and cost optimization.
- Troubleshooting: Address and resolve production issues, equipment breakdowns, and deviations promptly to minimize downtime.
2. Quality & Compliance (cGMP):
- SOP Adherence: Ensure strict adherence to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP) throughout the production lifecycle.
- Documentation: Review and approve Batch Production Records (BPRs), equipment logs, and production-related documents for completeness, accuracy,and compliance before submission to the Quality Assurance (QA) team.
- Deviation Handling: Lead the investigation and reporting of production deviations, incidents, and non-conformances using root cause analysis (RCA) tools. Develop and implement CAPAs (Corrective and Preventive Actions).
- Regulatory Readiness: Prepare and maintain the production area for internal and external regulatory audits (e.g., USFDA, WHO-GMP, EU-GMP).
3. Safety, Health, and Environment (SHE):
- Safety Protocols: Enforce rigorous safety protocols, especially when handling hazardous chemicals, solvents, and high-pressure reactions.
- Training: Ensure all production personnel receive mandatory training on safety procedures, material handling, fire safety, and the use of Personal Protective Equipment (PPE).
- Waste Management: Oversee proper segregation, handling, and disposal of process waste in coordination with the EHS team.
4. People Management & Leadership:
- Team Supervision: Manage, train, and mentor a team of Production Supervisors, Chemists, and Operators.
- Performance: Conduct performance reviews, identify training needs, and foster a culture of ownership, accountability, and continuous improvement.
- Inter-Departmental Coordination: Collaborate closely with Quality Control QC), Quality Assurance (QA), Engineering, R&D, and Supply Chain to ensure smooth operation flow.
experience
15
show more
Role Summary
The Production Manager will be responsible for leading and managing all day-to-day
manufacturing activities within the Active Pharmaceutical Ingredient (API) unit. The
role ensures efficient, cost-effective, and quality-compliant production in line with Good
Manufacturing Practices (GMP) and regulatory standards, meeting defined production
schedules and targets.
Key Responsibilities
...
1. Manufacturing Operations & Efficiency.
- Production Planning: Implement and execute the daily, weekly, and monthly production schedules for various API products to meet delivery timelines.
- Process Management: Oversee all unit operations, including reaction, filtration, distillation, drying, and packing, ensuring processes are executed as per approved Batch Production Records (BPRs).
- Yield & Cycle Time: Continuously monitor and analyze key performance indicators (KPIs) such as yield, batch cycle time, and capacity utilization to drive operational efficiency and cost optimization.
- Troubleshooting: Address and resolve production issues, equipment breakdowns, and deviations promptly to minimize downtime.
2. Quality & Compliance (cGMP):
- SOP Adherence: Ensure strict adherence to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP) throughout the production lifecycle.
- Documentation: Review and approve Batch Production Records (BPRs), equipment logs, and production-related documents for completeness, accuracy,and compliance before submission to the Quality Assurance (QA) team.
- Deviation Handling: Lead the investigation and reporting of production deviations, incidents, and non-conformances using root cause analysis (RCA) tools. Develop and implement CAPAs (Corrective and Preventive Actions).
- Regulatory Readiness: Prepare and maintain the production area for internal and external regulatory audits (e.g., USFDA, WHO-GMP, EU-GMP).
3. Safety, Health, and Environment (SHE):
- Safety Protocols: Enforce rigorous safety protocols, especially when handling hazardous chemicals, solvents, and high-pressure reactions.
- Training: Ensure all production personnel receive mandatory training on safety procedures, material handling, fire safety, and the use of Personal Protective Equipment (PPE).
- Waste Management: Oversee proper segregation, handling, and disposal of process waste in coordination with the EHS team.
4. People Management & Leadership:
- Team Supervision: Manage, train, and mentor a team of Production Supervisors, Chemists, and Operators.
- Performance: Conduct performance reviews, identify training needs, and foster a culture of ownership, accountability, and continuous improvement.
- Inter-Departmental Coordination: Collaborate closely with Quality Control QC), Quality Assurance (QA), Engineering, R&D, and Supply Chain to ensure smooth operation flow.
experience
15
show more