Production Head

Job Description

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 .