About The Role

Description: The role is responsible for ensuring current Good Manufacturing Practices (cGMP – Current Good Manufacturing Practices) compliance and supervising overall production activities in the injectable manufacturing area during the assigned shift. The incumbent ensures safe, compliant, and efficient sterile manufacturing operations, covering General, Control, and Aseptic areas. The role focuses on line readiness, validated and calibrated equipment status, documentation accuracy, and adherence to approved Standard Operating Procedures (SOPs – Standard Operating Procedures). It also involves reviewing and maintaining online production documents, coordinating with Quality Assurance (QA – Quality Assurance), Engineering, and Supply Chain teams, and driving consistent execution of production plans while complying with regulatory expectations, data integrity standards, and safety guidelines to ensure uninterrupted supply of high-quality injectable products.

Essential Functions

Ensure compliance with cGMP (Current Good Manufacturing Practices) and GDP (Good 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.