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.

Skills Required