Production Manager

<p><b>Role: </b> Manager (M2) - Production </p><p><b>Location: </b> Pithampur Unit-3 </p><p><b>Reports To: </b> Senior Manager / Plant Production Head </p><p><b>Experience Required: </b> Min 15 years in Pharmaceutical manufacturing with exposure to regulatory-approved facilities (USFDA, MHRA, EU, etc.). </p><p><b>Specialization: </b> Derma, Nasal, Liquid Oral dosage forms </p><p><b>Education: </b> </p><ul><li>B.Pharm / M.Pharm </li><li>B.E. / B.Tech </li><li>M.Sc. (Chemistry, Biotechnology, Pharmacy, or related disciplines) </li> </ul><p><br /></p><p><b>Key Expectations </b> </p><p><b>Production Management </b> </p><ul><li>Execute manufacturing and filling activities as per plan. </li><li>Achieve production targets and schedule adherence. </li><li>Ensure optimum utilization of manpower, equipment, materials, and utilities. </li><li>Handle SAP, Viva, eBMR/EBR, and PAS-X MES systems. </li> </ul><p><b>Quality &amp; Compliance </b> </p><ul><li>Ensure compliance with cGMP, Data Integrity, and regulatory requirements. </li><li>Maintain audit readiness for USFDA, MHRA, EU, WHO, etc. </li><li>Manage deviations, investigations, CAPA, OOS/OOT, and market complaints. </li><li>Support validation, qualification, and technology transfer activities. </li> </ul><p><b>Operational Excellence </b> </p><ul><li>Improve productivity, yield, and cycle times. </li><li>Drive Lean Manufacturing and Six Sigma initiatives. </li><li>Reduce manufacturing costs (COGM, CCPC). </li><li>Lead waste reduction and process optimization projects. </li> </ul><p><b>Equipment &amp; Facility Management </b> </p><ul><li>Ensure equipment reliability and uptime. </li><li>Coordinate preventive maintenance and breakdown management. </li><li>Support automation, digitization, and 21 CFR Part 11 compliance. </li><li>Participate in expansion and modification projects. </li> </ul><p><b>Safety &amp; EHS </b> </p><ul><li>Promote zero-accident culture. </li><li>Conduct risk assessments and incident investigations. </li><li>Drive safety observations and corrective actions. </li> </ul><p><b>People Leadership </b> </p><ul><li>Develop production teams through training and coaching. </li><li>Conduct Gemba, SOP, and capability-building sessions. </li><li>Manage performance, engagement, and succession planning. </li> </ul><p><br /></p><p><b>Major KPIs </b> </p><p><b>Safety </b> </p><ul><li>Zero Lost Time Accidents (LTA) </li><li>Near-miss reporting and closure </li><li>Safety observation closure rate </li> </ul><p><b>Quality </b> </p><ul><li>Right First Time (RFT) </li><li>Deviation reduction </li><li>CAPA closure compliance </li><li>Audit observation management </li> </ul><p><b>Delivery </b> </p><ul><li>Schedule adherence </li><li>OTIF manufacturing performance </li><li>Batch release support timelines </li> </ul><p><b>Cost </b> </p><ul><li>COGM reduction </li><li>CCPC reduction </li><li>Yield improvement </li><li>Cost-saving projects </li> </ul><p><b>Productivity </b> </p><ul><li>OEE improvement </li><li>Throughput enhancement </li><li>Cycle time reduction </li><li>Capacity utilization </li> </ul><p><b>People </b> </p><ul><li>Training compliance </li><li>Attrition control </li><li>Succession readiness </li><li>Employee engagement </li> </ul><p><b>Technical Competencies </b> </p><ul><li>cGMP &amp; Regulatory Compliance </li><li>Investigation &amp; CAPA </li><li>Validation &amp; Qualification </li><li>Lean Manufacturing &amp; Operational Excellence </li><li>Data Integrity &amp; 21 CFR Part 11 </li><li>Risk Management </li> </ul><p><b>Behavioral Competencies </b> </p><ul><li>Leadership &amp; Team Building </li><li>Decision Making </li><li>Problem Solving </li><li>Stakeholder Management </li><li>Communication Skills </li><li>Continuous Improvement Mindset </li> </ul>