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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.
Job Responsibility:
Lead and manage all day-to-day manufacturing activities within the Active Pharmaceutical Ingredient (API) unit
Ensure efficient, cost-effective, and quality-compliant production
Meet defined production schedules and targets
Implement and execute daily, weekly, and monthly production schedules
Oversee unit operations (reaction, filtration, distillation, drying, packing)
Monitor and analyze KPIs (yield, batch cycle time, capacity utilization)
Address and resolve production issues, equipment breakdowns, and deviations
Ensure strict adherence to SOPs and cGMP
Review and approve Batch Production Records (BPRs), equipment logs, and production documents
Lead investigation and reporting of production deviations using RCA
Develop and implement CAPAs
Prepare and maintain production area for regulatory audits
Enforce safety protocols for hazardous materials
Ensure personnel receive mandatory safety training
Oversee proper waste segregation, handling, and disposal
Manage, train, and mentor team of Production Supervisors, Chemists, and Operators
Conduct performance reviews
Foster culture of ownership, accountability, and continuous improvement
Collaborate with Quality Control, Quality Assurance, Engineering, R&D, and Supply Chain
Requirements:
15 years of experience
Experience in Active Pharmaceutical Ingredient (API) unit manufacturing
Knowledge of Good Manufacturing Practices (GMP) and regulatory standards
Experience with production planning and scheduling
Experience in process management (reaction, filtration, distillation, drying, packing)
Experience with Batch Production Records (BPRs)
Experience monitoring KPIs (yield, batch cycle time, capacity utilization)
Experience troubleshooting production issues and equipment breakdowns
Experience with Standard Operating Procedures (SOPs) and cGMP
Experience with production documentation review and approval
Experience with deviation handling, root cause analysis (RCA), and CAPAs
Experience with regulatory audits (e.g., USFDA, WHO-GMP, EU-GMP)
Knowledge of safety protocols for hazardous chemicals, solvents, and high-pressure reactions
Experience with safety training and PPE
Experience with waste management
Experience in team supervision, training, and mentoring