AGM- Production (Regulatory Plant)

Role & responsibilities

• Responsible for overall operations of OSD.

• Coordinating with warehouse, QA, QC for the material availability, its release and scheduling the batch production to meet the market requirements.

• Monitor and ensure right first-time production as per plan while ensuring adherence to production related policies & procedures and Quality & EHS standard.

• Prepare daily production reports and batch allocation.

• Provide timely feedback to superior on deviations observed during manufacturing and

  packing activities and suggesting appropriate corrective & preventive actions.

• Responsible for planning, coordination, and control of manufacturing process to ensure that the products are produced efficiently, and the correct amount is produced at the right cost and level of quality.

• Ensure the production is on time, meeting quality standards and as per specifications.

• Team Management - Performance goal setting for team, review team performance.

  Counseling, training, and developing the Human resource of the department. Ensuring optimum manpower utilization.

• Training to production and cross functional employees related to current regulatory updation and for new entrant.

• Ensure maintenance of documentation as per required guidelines and other quality

  standards updated by the organization.

• Ensure capacity utilization of all equipments in production areas.

• Propose & implement product improvement & operational efficiency improvement measures. Work towards yield improvement.

• Manage regulatory and customer audits.

• Ensure that products are packed strictly as per MPCR to attain quality products.

• Procure machine spares, change parts, and other departmental needs.

• Ensure maintenance of cleanliness and hygiene in the sterile, manufacturing and ancillary area.

• Comply and ensure the implementation of safety practices.

• Authorize to create process orders, material checks, batch closing and process orders in SAP.

• Work with QA/QC department for validation activities, the engineering department for preventive maintenance and with QA for the investigation of market complaints.

• Ensured accurate daily/weekly/monthly planning and execution as per CGMP/productivity norms with proper compliance to regulatory norms and reduced the market compliances.

• To co-ordinate with other functions like manufacturing, QA. QC, supply Chain and Scheduling the production and packing Activity.

• Overall responsibility of action plan on internal and external audit and its compliance related to production department.

• Ensure that all personnel are followed SOP and cGMP practices in the department.

• Participation in validation, qualification and customer complaint investigation.