Senior Manager - Production

Unichem Laboratories Limited; Solan; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Unichem Laboratories Limited in India seeks an experienced Production/Manufacturing leader to plan, execute and monitor monthly manufacturing and packing plans across Units I-III to meet market demand. The role requires strong cGMP knowledge, cross-functional collaboration, and ability to drive CAPA and continuous improvements.

Ideal candidates will have a proven track record in pharmaceutical manufacturing, process validation, and regulatory audits, with leadership capabilities to develop a

Qualifications

• Should have handled production department in a reputed pharmaceutical organization
• Strong expertise in pharmaceutical manufacturing processes, technology transfer, and process validation batches.
• Should have faced regulatory and customer audits.
• In-depth knowledge of cGMP regulations, international pharma guidelines, and Quality Management Systems (QMS).
• Proven capability in handling root cause analysis for OOS, deviations, and implementing strong CAPA.
• Experience in production planning, scheduling, capacity utilization, and shop floor management.
• Excellent leadership, team management, and mentoring skills to build and develop a second line of leadership.
• Strong cross-functional coordination and communication skills to handle audits and engineering calibrations.

Responsibilities

• Plan, execute, and monitor monthly manufacturing and packing plans across units to meet market requirements.
• Ensure strict compliance with cGMP, regulatory guidelines, and QMS requirements.
• Maintain shop floor discipline, plant safety, hygiene to ensure zero-incident operations.
• Review and implement SOPs, batch records, master documents, and compliance records.
• Investigate deviations, non-compliances, market complaints, OOS results.
• Implement CAPA to eliminate repeated complaints and recall risks.
• Authorize and approve artwork, batch allocations, deviations, change controls, and CAPA docs.
• Coordinate with QA/QC, Engineering, and Sales for validation and dispatch planning.
• Monitor cost per unit by improving yield, efficiency, and reducing manpower through automation.
• Handle audits by customers, internal and external regulatory bodies successfully.
• Conduct technical and cGMP training programs for subordinates to build multi-skilled team.
• Manage administrative functions including recruitment, shift-wise manpower planning, and mentoring.

Job description

• Plan, execute, and monitor monthly manufacturing and packing plans across multiple units (Unit I, II & III) to meet market requirements.
• Ensure strict compliance with cGMP, international regulatory guidelines, and Quality Management System (QMS) requirements.
• Maintain work discipline, plant safety, housekeeping, and hygiene standards on the shop floor to ensure zero-incident operations.
• Review and implement Standard Operating Procedures (SOPs), batch manufacturing records, master documents, and compliance records.
• Investigate process deviations, non-compliances, market complaints, product failures, and Out of Specification (OOS) results.
• Implement strong Corrective and Preventive Actions (CAPA) to eliminate repeated complaints, rejections, and product recall risks.
• Authorize and approve artwork, batch allocations, deviations, change controls, and CAPA documents in the plant.
• Coordinate with cross-functional teams like QA/QC, Engineering, and Sales for validation, preventive maintenance, and dispatch planning.
• Monitor and control the cost per unit by improving yield, enhancing operational efficiency, and reducing manpower through automation.
• Handle customer audits, internal audits, and external regulatory body inspections successfully.
• Conduct regular technical and cGMP training programs for subordinates, staff, and technicians to develop a multi-skilled team.
• Manage administrative functions, including recruitment, shift-wise manpower planning, and performance mentoring of the team.
• Plan, execute, and monitor monthly manufacturing and packing plan of Baddi Unit-1 to meet market requirements

Desired Skills

• Should have handled production department in a reputed pharmaceutical organization
• Strong expertise in pharmaceutical manufacturing processes, technology transfer, and process validation batches.
• Should have faced regulatory and customer audits.
• In-depth knowledge of cGMP regulations, international pharma guidelines, and Quality Management Systems (QMS).
• Proven capability in handling root cause analysis for OOS, deviations, and implementing strong CAPA.
• Experience in production planning, scheduling, capacity utilization, and shop floor management.
• Excellent leadership, team management, and mentoring skills to build and develop a second line of leadership.
• Strong cross-functional coordination and communication skills to handle audits and engineering calibrations.