Block Incharge

Job Title:

Department:

Job Purpose:

To oversee and manage day-to-day operations of the API production block, ensuring efficient, safe, and compliant manufacturing of Active Pharmaceutical Ingredients in accordance with cGMP and regulatory requirements.

Key Responsibilities:

Production Management:

• Plan, coordinate, and execute API production schedules to meet manufacturing targets.
  
• Monitor daily production activities, troubleshoot process issues, and ensure minimal downtime.
  
• Ensure proper batch documentation as per cGMP and SOPs.
  
• Coordinate with QA/QC, Engineering, EHS, and other departments to ensure smooth production flow.
  

Compliance and Documentation:

• Ensure strict adherence to GMP, regulatory, and safety guidelines.
  
• Review and approve batch manufacturing records (BMR), logbooks, and other documentation.
  
• Participate in internal and external audits (USFDA, EU, WHO, etc.) and implement corrective actions.
  

Team Management:

• Lead and supervise production operators, shift chemists, and technical staff.
  
• Provide training on SOPs, safety practices, and equipment handling.
  
• Maintain discipline and productivity within the team.
  

Process Improvement:

• Identify process inefficiencies and work with R&D or process teams to optimize yields, reduce waste, and improve productivity.
  
• Support technology transfer and scale-up activities from R&D to commercial scale.
  

Equipment & Facility Oversight:

• Ensure all equipment is calibrated, qualified, and maintained.
  
• Coordinate with maintenance for timely servicing and breakdown response.
  

Skills & Competencies:

• Strong understanding of chemical processes in API manufacturing.
  
• Sound knowledge of cGMP, ICH, and regulatory requirements.
  
• Leadership and team management abilities.
  
• Analytical thinking and problem-solving.
  
• Excellent communication and coordination skills.