Production Head For Dry Powder Injectables

4 weeks ago

Kolkata West Bengal, India RECEX Full time

experience of 4-5 years in the same position preferred in Beta lactum Dry Powder Injectables and Dialysis fluids in Powder and Liquid forms Key Responsibilities Production Operations Plan organize and manage the overall production activities for the Dry Powder Injectable section Ensure production targets are achieved as per monthly and annual schedules Oversee batch manufacturing filling lyophilization and packaging operations Review and approve BMRs Batch Manufacturing Records SOPs and production documents Coordinate with QA QC Engineering and Stores for smooth plant operations Compliance Quality Ensure compliance with cGMP WHO USFDA and other international regulatory standards Prepare and face regulatory audits and client inspections Ensure proper documentation equipment qualification and process validation Monitor and maintain cleanroom standards and environmental controls People Resource Management Lead and mentor the production team ensuring training motivation and performance management Plan manpower requirements and ensure optimum utilization of workforce and resources Promote a culture of discipline safety and continuous improvement Safety Maintenance Ensure strict adherence to EHS Environment Health Safety norms and aseptic practices Coordinate preventive maintenance of machines and utilities with the Engineering department Implement corrective and preventive actions for deviations and breakdowns Process Improvement Cost Control Drive process optimization yield improvement and waste reduction initiatives Monitor production costs and ensure efficient utilization of materials and energy Implement lean manufacturing and Kaizen practices Key Skills Competencies Strong technical expertise in Dry Powder Injectable manufacturing and aseptic operations In-depth knowledge of GMP documentation validation and regulatory compliance Excellent leadership communication and team management skills Analytical and problem-solving mindset with attention to detail Proficient in MS Office SAP ERP systems and production data analysis Preferred Background Experience in parenteral formulations particularly Dry Powder Injectables Cephalosporin Non-Cephalosporin Exposure to regulatory audits WHO-GMP USFDA EU MHRA etc Hands-on experience with lyophilization filling line and cleanroom management

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