Qualification - B Pharma / M Pharma

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.

Desired Skills

- Should have handled production department in a reputed pharmaceutical organization
- Solid 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.

📌 Senior Manager - Production (Baddi)
🏢 Unichem Laboratories
📍 Baddi