Associate General Manager - Production (Formulation)

Piramal Pharma Limited; Pithampur; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Piramal Pharma Limited in Pithampur, MP, seeks a seasoned manufacturing professional to plan and execute monthly production across multiple Non-sterile lines, ensuring operations run in strict accordance with cGMP standards.

You will lead regulatory audits, drive continuous improvement, mentor staff, implement change controls and CAPA, and support cost optimization while ensuring on-time supply and quality across packaging and processing activities.

Responsibilities

• Plans/schedules for manufacturing activities across the month over various lines.
• Ensures all processing and packing lines run in conformance to cGMP standards.
• Follows regulations of USFDA, TGA, MHRA, MPA, WHO, Schedule M etc.
• Participates in validation, tech transfer per protocol.
• Trains subordinates to improve process compliance and documentation.
• Monitors line performance, addresses deviations and NCs.
• Reviews RFPs and participates in customer calls for inputs.
• Involves in regulatory, customer and internal audits.
• Ensures no shortfall in supply and manages fluctuations in demand.
• Reviews and approves Batch Processing Records and quality documents.
• Budgeting, manpower planning, Capex/Opex finalization.

Job description

• 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 SOP’s after updation.
• Initiate / Review/ Approve Change controls and Deviations, CAPA, Change controls in electronic system as per the need.