Supervise and verify critical process parameters as per Batch Manufacturing Records (BMR) and Standard Operating Procedures (SOP) to maintain control during shifts.
Conduct technical calculations, including heat and mass transfer, and manage solvent recovery
Perform energy calculations and prepare detailed energy and production reports (daily-weekly-monthly) as required.
Oversee facility upkeep, cGMP compliance, manpower planning, and resource optimization for effective production operations.
Coordinate with Warehouse and SCM to assess raw material requirements and maintain smooth production flow.
Ensure compliance with budgeted raw material consumption norms and yield targets for cost-efficient production.
Manage Quality Management System (QMS) activities, such as OOS, Change Control, Deviation, and CAPA, and ensure all documentation is accurate and complete.
Track, assess, and control production-related SAP activities to monitor progress and enhance efficiency.
Drive safe operations, resource utilization, and adherence to production schedules while minimizing time cycles.
Prepare and review production logs (area cleaning, weight balance calibration, training records) to support quality standards and operational efficiency.
Assess training needs, organize sessions for team development, and foster problem-solving skills.
Generate and analyze performance reports to compare planned versus actual output, identifying reasons for any deviations.
Work with Quality Control, Engineering, and Quality Assurance teams to meet production requirements and address operational needs.
Participate in internal and external audits, ensuring compliance with quality, yield, safety, and plant upkeep standards.
Optimize plant capacity utilization and resource allocation, aligning with cost-control measures.
Requirements:
B.Tech, Chemical Engineer with 5-8 years of experience in API Manufacturing
Proficiency in SAP, QMS activities, and cGMP compliance.
Strong coordination skills to enhance efficiency and collaboration across departments.
A focus on safety, quality, and continuous improvement in all aspects of production management.
