Block Incharge

Key Responsibilities

Production Operations

• Lead and supervise day-to-day production activities of the assigned API manufacturing block.
• Ensure execution of batch manufacturing as per approved Batch Manufacturing Records (BMRs), SOPs, and process instructions.
• Monitor critical process parameters and ensure adherence to established process specifications.
• Plan manpower deployment and shift-wise activities to achieve production schedules.
• Coordinate with QA, QC, Warehouse, Engineering, EHS, and Maintenance departments for smooth operations.
• Ensure timely completion of batches and optimum utilization of equipment and resources.

Compliance & Documentation

• Ensure compliance with cGMP, ICH, WHO-GMP, USFDA, and other applicable regulatory requirements.
• Review production records, logbooks, equipment usage records, and batch documentation.
• Ensure proper documentation practices in accordance with ALCOA+ principles.
• Participate in internal and external audits and support audit readiness activities.

Safety, Health & Environment (EHS)

• Promote and implement safe working practices within the production block.
• Ensure adherence to EHS guidelines, Permit-to-Work systems, PPE usage, and hazardous chemical handling procedures.
• Conduct safety inspections and report unsafe conditions immediately.
• Participate in incident investigations and implement corrective and preventive actions.

Team Management

• Supervise Production Officers, Operators, Technicians, and Contract Workforce.
• Conduct on-the-job training and skill development programs.
• Monitor team performance and ensure discipline, attendance, and productivity.
• Foster a culture of compliance, teamwork, and continuous improvement.

Equipment & Process Management

• Ensure proper operation and maintenance of reactors, centrifuges, dryers, filters, scrubbers, and other process equipment.
• Coordinate preventive maintenance and equipment qualification activities.
• Identify process improvements for yield enhancement, cycle time reduction, and cost optimization.
• Support technology transfer and scale-up activities for new products.

Deviation & Investigation Management

• Participate in deviation investigations, OOS, change controls, CAPA implementation, and risk assessments.
• Ensure timely closure of production-related compliance observations.

Educational Qualification

• B.Sc / M.Sc (Chemistry)
• B.Tech / M.Tech (Chemical Engineering)
• Diploma in Chemical Engineering (with relevant experience)

Experience

• 8 to 15 years of experience in API pharmaceutical manufacturing.
• Minimum 3-5 years of experience in handling an independent production block.
• Experience in multi-product API plants and regulatory-compliant facilities is preferred.