Job Description

Key Roles/Responsibilities:

• Allocates workmen for different workstations on shift-to-shift basis.
• Ensure no stoppage of operation / machines due to non-availability of manpower and any kind of machine breakdown.
• Supervises the line operations and participate in Validation activities as per the protocol.
• Maintains c-GMP practices along with documentations in various records.
• Fills and checks BMR / BPR before submission to the superiors.
• Handles minor parametric setting issues in various machines and products.
• Monitors speed of machine and output according to the run time.
• Imparts on job / Classroom training to the concern workmen and supervisor for SOP and cGMP systems.
• Imparts induction activity to all new joining.
• Monitors and reports the unauthorized movement of workmen from line.
• Takes up the responsibilities of the immediate supervisor for the section in his absence.
• Helps section in charge in preparation of SOP.
• Verifies the balances on daily and monthly basis.
• Participate in machine qualification activities.
• Checks all the calibration tags of equipment, instruments, or fire extinguisher for their due date time to time.
• Knowledge and involvement in EHS, SFTI & 6S Activities.
• Knowledge and involvement in ISO 14000 & 13485.
• Any other activity from time to time which his supervisor / company feels appropriate.
• Checking of line clearance during batch change over.
• In process testing as defined in Batch Manufacturing Record.
• Approval of Material Return Note (MRN), Material Requisition Note (MRQN),

Line rejection Note (LRN) of Processing area.


• Review the Batch Manufacturing and other quality documents.
• To perform challenge test as per the BMR / SOP with define frequency.