Job Purpose
To lead and manage API production operations, ensuring safe, efficient, compliant and cost-effective manufacturing of Active Pharmaceutical Ingredients (APIs) in accordance with cGMP, regulatory requirements, EHS standards and approved production plans. The role is responsible for production planning, process execution, resource utilization, batch quality, productivity improvement and development of the production team.
2. Key Responsibilities
A. API Production Operations
• Lead day-to-day API manufacturing operations, ensuring adherence to approved batch manufacturing records (BMRs), standard operating procedures (SOPs) and production schedules.
• Manage end-to-end manufacturing processes, including charging, reactions, distillation, extraction, crystallization, filtration, drying, milling, blending and packing, as applicable.
• Ensure timely execution and completion of production batches in line with approved plans and customer requirements.
• Monitor batch cycle times, yields, solvent recovery, equipment utilization and process performance.




• Coordinate with Production Planning, Quality Assurance, Quality Control, Engineering and Warehouse teams to ensure uninterrupted manufacturing operations.
• Ensure proper execution of shift handovers and effective deployment of manpower across production shifts.

B. cGMP and Regulatory Compliance
• Ensure compliance with current Positive Manufacturing Practices (cGMP), applicable regulatory requirements and company quality systems.
• Review and ensure accurate completion of BMRs, logbooks, equipment usage records and other production documentation.
• Ensure compliance with data integrity requirements, documentation practices and audit-trail controls.
• Investigate deviations, batch failures, out-of-specification (OOS) results and process discrepancies in coordination with QA and QC.
• Drive CAPA implementation, change control, risk assessments and prevention of recurring quality issues.
• Support internal audits, cus

📌 AGM:- Production (Ankleshwar)
🏢 Cadila Pharmaceuticals
📍 Ankleshwar