Company: Sun Pharmaceutical Industries Ltd
Experience: 12 to 15 Yrs in regulated Plants
Education: M.Sc / B.Pharm / M.Pharm
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, manpower 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 a high degree of morale and 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 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 SOPs and instructions related to production areas are implemented as per procedure.Review and approval of standard operating procedures, specifications 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 complaints received 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 systems and equipment are upgraded, validated, and automated as per the procedures and requirements.To ensure adherence to the organization's environment, health, and safety norms.Responsible for creation and release of process orders for manufacturing and packing of commercial batches.
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