Key Roles/Responsibilities:

• Allocates workmen for different workstations on shift-to-shift basis.
• Ensure no stoppage of operation / machines due to non-availability of man power 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 in process parameters & manufacturing documentations.
• Involvement in the manufacturing and documentation of Pilot batches in the existing Pilot plant in conformance with cGMP.
• Involvement in the manufacturing and documentation of trial/pre exhibit/ exhibit /commercial batches.
• Fills and checks BMR 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.
• Checks the compressed tablets/coated tablets/filled capsules randomly. If any discrepancy is observed, reports to superiors.
• Monitors and reports the unauthorized movement of workmen from line.
• Takes up the responsibilities of the immediate supervisor for the section in his absence.
• Verifies the balances on daily and monthly basis.
• Participate in machine qualification activities.
• Checks all the calibration tags of equipment, instruments and fire extinguisher for their due date time to time.
• Knowledge and involvement in SFTI & 5S Activities.
• Knowledge and involvement in ISO 14000 & 13485.
• Any other activity from time to time which his supervisor / company feel appropriate.
• Checking of line clearance during batch change over.
• In process testing as defined in Batch Manufacturing Record.
• Perform summary after completion of sub-process like compression and coating.
• Review quality document.