Essential Functions:
Ensure compliance with cGMP (Current Valuable Manufacturing Practices) and GDP (Positive 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
M. Pharm M. Pharm - Preferred
Experience:
12 years or more in 12 - 15 Years
Specialized Knowledge: Licenses:
📌 Deputy Manager, Manufacturing Injectables Ahmedabad (India)
🏢 Amneal
📍 India