Associate General Manager - Production

Role & responsibilities

Plans/Schedules for manufacturing (processing) activities across the month over various lines along with execution of manufacturing (processing) activities of Non-sterile department.

• Ensures, on regular basis, that all the processing and packing lines should run in conformance to cGMP standards.

• Follows the regulation of various agencies (USFDA, TGA, MHRA, MPA, WHO, Schedule M etc.).

• Conducts Departmental meeting A two-way communication process for reviewing various points for improvement in the department. • Participate in validation activities, tech transfer activities as per the protocol.

• Training to subordinate to improve process related practices and documentation.

• Counsels erring workmen in case discrepancy are found in output based on machine speed verses run time.

• Monitors shop floor NCs by counselling of erring workmen and display on notice board, initiate disciplinary action.

Monitors on regular basis parameters having financial impact like yield, packing material consumption, operational lead time, labor utilization and take measure for continuous optimization/improvement.

• Review of various RFPs (Request for Proposal) from customers and preparing Gap analysis.
• Participate in various customer calls and provide inputs.
• Involve in various Regulatory, Customer and Internal audits.
• Ensures no shortfall in supply to market. Take care of sharp fluctuations like sudden demand spikes.
• Follow the GDP and reviews various reports/ records of the department. • Sets objectives (Annual) for individual repetitions and monitors the progress. Gives periodic feedback regarding performance. Guides whenever necessary in case of difficulty in execution of any objective.
• Conducts final performance reviews sitting with individuals representatives along with the HOD and sends the reports to personnel dept. Recommends for performance grades for each reportees.
• Suggest and implement various cost optimization/de-bottlenecking projects.
• Helps in line setting for new products with new pack profile.
• Helps in investigating market complaints.
• Review and approve the Batch Processing records (BMR) and other quality documents.
• Involvement in various Capex and Opex finalization. • Budget preparation and Manpower planning.
• Prepares capital investment requisitions for any new product/modification of existing facility.
• Takes up the responsibilities of the immediate superior in his absence. • Approve new SOP and existing SOPs after updation.
• Initiate / Review/ Approve Change controls and Deviations, CAPA, Change controls in electronic system as per the need.
• Knowledge and involvement in Performance management system, ISO 14001 & 13485 Activities. Any other activity from time to time which his supervisor / company feels appropriate.
• Collaborate with cross-functional teams to define and document business requirements for the system.
• • Customize the system to meet specific Manufacturing needs, including workflow automation, inventory management, and production planning.
• • Monitor system performance and security, ensuring compliance with company policies and regulations.
• • Collaborate with IT teams and external consultants to enhance system capabilities and integrated new technologies as needed. • Lead change management initiative to drive user adoption and maximize the benefits of the system.
• Provide required resources and support to DICO and participate in the steering committee meetings. •
• Takes up the responsibilities of the immediate supervision for the section in his absence.
• Participate in senior management / HOD (head of department) review meeting, takes corrective measures, whenever necessary.