Assistant Manager

Documentation & SOP Management

• Prepare and implement standard operating procedures, batch manufacturing records, protocols, cleaning procedures, and log sheets.
• Maintain all documentation in compliance with cGMP and regulatory requirements.
• Ensure timely review and revision of SOPs related to FP departments.

Quality & Compliance Activities

• Handle QMS activities including change controls, deviations, incidents, and risk assessments.
• Perform DQ, IQ, OQ, and PQ qualifications for equipment.
• Support in audit preparedness and ensure all documentation is audit-ready.

Training & Team Management

• Ensure departmental employees are trained as per the TRIMS training schedule.
• Attend and ensure participation in all relevant training programs, including cGMP and equipment-specific SOPs.

Production & Execution

• Execute formulation and aseptic filling activities in line with the production plan.
• Lead simulation trials like media fills and ensure compliance in aseptic processing areas.
• Achieve planned FP targets while strictly adhering to cGMP guidelines.

Equipment Maintenance & Coordination

• Coordinate with Engineering and QA for execution of preventive maintenance plans.
• Monitor equipment performance and initiate necessary actions to ensure uninterrupted operations.

Reporting & Communication

• Perform daily operations as per schedule and report all activities, deviations, and issues to the reporting officer promptly.
• Maintain logbooks and ensure batch documentation is updated in real-time.