Production Head for Dry Powder Injectables

Job Description:

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.