Essential Functions:
• Ensure compliance with cGMP (Current Valuable Manufacturing Practices) and GDP (Valuable Documentation Practices) across General, Control, and Aseptic areas
• Supervise overall injectable production activities during the assigned shift
• Ensure all equipment and manufacturing lines are validated and calibrated before use
• Perform and verify line clearance activities prior to batch commencement
• Handle Change Control, Deviations, Investigations, and CAPA (Corrective and Preventive Action) processes
• Review, approve, revise, and implement SOPs (Standard Operating Procedures) for sterile manufacturing
• Monitor execution of production plan vs actual output on daily and monthly basis
• Ensure strict adherence to aseptic techniques and contamination control practices
• Oversee cleaning, sanitization, and environmental monitoring activities
• Coordinate with QA, QC, Engineering, and Warehouse for seamless operations
• Review and maintain online production and batch documentation
• Responsible for preparation & review of the all-master documents of production
• Responsible to update on self-hygiene
• Responsible to attend the training as per training schedule and to ensure training of the team as per TNI
• Support audit readiness and regulatory inspections as required
Additional Responsibilities:
• Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.
• Responsible to give training to all the subordinates, technicians, and operators of the department. Responsible to update on self-hygiene.
• Responsible to attend the training as per training schedule and to ensure training as per TNI.
Qualifications
Education:• B. Pharm B. Pharm - Required