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
Robust 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, devia

📌 Senior Manager (Baddi)
🏢 Unichem Laboratories
📍 Baddi