Associate General Manager-Production

Piramal Pharma Limited; Dhar; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Piramal Pharma Solutions is seeking an Associate General Manager-Production to lead OSD and Sterile manufacturing, oversee planning, audits, customer interactions, safety and quality compliance. You will drive monthly production plans across lines, ensure cGMP conformance, and coordinate audits and validations.

The role requires strategic oversight, line setting for new products, and mentoring staff. Strong quality systems, regulatory knowledge, and cost optimization focus are essential for

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 SOP’s 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.

Job description

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Associate General Manager-Production

Job Description

Head OSD & Sterile manufacturing will take care of planning, audits, customer call, safety and quality compliance etc.

• undefined
• 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.
• Knowledge and involvement in Performance management system, ISO 14001 & 13485 Activities.

Any other activity from time to time which his supervisor / company feels appropriate.