Senior Manager - Production

Unichem Laboratories

Solan

On-site

INR 1,500,000 - 2,300,000

Full time

14 days+
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Job summary

Unichem Laboratories is seeking an experienced Production/Plant Manager to plan, monitor, and optimize monthly manufacturing and packing plans across multiple units. The role emphasizes strict adherence to cGMP, QMS, and regulatory guidelines while driving efficiency and cross-functional collaboration.

The ideal candidate has strong pharma production experience, expertise in CAPA, OOS investigations, and robust leadership to build a capable team focused on quality and compliance.

Qualifications

  • Demonstrated experience in managing production departments in a reputed pharmaceutical organization.
  • Strong domain knowledge of pharmaceutical manufacturing processes and technology transfer.
  • Experience with process validation batches and regulatory audits.
  • In-depth understanding of cGMP regulations and international pharma guidelines.
  • Proven ability to analyze root causes for OOS and implement CAPA.
  • Experience in production planning, scheduling, and capacity utilization.

Responsibilities

  • Plan, execute, and monitor monthly manufacturing and packing plans across Unit I, II & III to meet market needs.
  • Ensure compliance with cGMP, regulatory guidelines, and QMS requirements.
  • Maintain shop floor discipline, safety, and hygiene to support zero-incident operations.
  • Review and implement SOPs, batch records, and master documents.
  • Investigate deviations, non-compliances, market complaints, product failures, and OOS results.
  • Drive CAPA to reduce complaints, rejections, and recall risks.
  • Authorize artwork, batch allocations, deviations, change controls, and CAPA documents.
  • Coordinate with QA/QC, Engineering, and Sales for validation, maintenance, and dispatch planning.
  • Monitor cost per unit by improving yield and reducing manpower via automation.
  • Handle customer audits, internal audits, and external regulatory inspections.
  • Conduct technical and cGMP training to develop multi-skilled teams.
  • Oversee administrative functions including recruitment, shift planning, and mentoring.

Skills

Production leadership
Pharma manufacturing
cGMP compliance
CAPA implementation
OOS investigations
Production planning
Shop floor management
Cross-functional coordination
Audits handling

Job description

RESPONSIBILITIES


  • 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.



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