Title:  Manager - 1 Packing

RESPONSIBILITIES :

• Responsible for Production operations and monitoring of commercial batches as per schedule. 
• Daily monitoring of line scheduling and review of plan vs actual. 
• Ensuring availability of resources like area, machine, man power for scale ups, Exhibit batches, pre validation batches, validation batches and commercial batches.
• To ensure that the products are manufactured and stored as per appropriate documents in order to obtain the required quality.
• To ensure that the production records are reviewed as per current procedures.
• To enforce and maintain high degree of morale, discipline amongst the team.
• Optimum utilization of resources. To ensure that optimum resources such as man, material and area are available for the smooth operation of production activities.
• To ensure the initial and continuing training of all the persons working in production is carried out as per schedule.
• To ensure that the subordinates are adequately trained for the job assigned.
• Implementation of Current Good Manufacturing Practices in production area to meet the Regulatory requirements.
• To ensure that all the SOP’s and instructions related to production areas are implemented as per procedure.
• Review and approval of Standard operating procedure, specification of raw materials, packaging material and drug products, validation, qualification protocols and reports.
• Implementation and Monitoring of Quality system :-

• Implementation of Quality system of Site and quality culture in Production area.
• Handling of Planned and Unplanned deviation, Investigation and Change control. Implementation of corrective and preventive action. Verification of effectiveness of the corrective and preventive action.
• Handling of Market complaint receive from the customer
• Responsible to perform the risk assessment in case of changes in facility / equipment, during investigation.   

• Review and approval of Master documents for exhibit batches and Commercial batches.
• To ensure the engineering activities such as preventive maintenance, routine and breakdown maintenance, calibration of equipment and area are carried out as per schedule.
• To ensure equipment, area and process validation are being carried out as per the schedule. 
• To ensure that all the systems and equipments are upgraded, validated and Automated as per the procedures and requirements.
• To ensure adherence to the organization Environment, Health and Safety norms.
• Responsible for creation and release of process order for manufacturing and packing of commercial batches