Job
Description
Oversee daily manufacturing operations of injectable formulations, ensuring adherence to quality, safety, and compliance norms. Drive production planning in alignment with business needs, ensuring optimum utilization of resources (manpower, materials, and equipment). Ensure strict compliance with cGMP, FDA, MHRA, EU-GMP, and other regulatory guidelines. Coordinate with QA/QC, Engineering, SCM, and R&D for seamless operations and troubleshooting. Lead investigations and CAPAs for deviations, OOS, and market complaints. Implement and drive continuous improvement initiatives – lean manufacturing, Six Sigma, Kaizen, etc. Monitor key performance indicators (KPIs) – productivity, yield, downtime, cost efficiency. Manage and develop a high-performing team, fostering a culture of ownership, discipline, and collaboration. Assist in audits – regulatory, customer, and internal – and ensure timely closure of observations. Participate in technology transfers, validation batches, and new product introductions (NPIs). Ensure workplace safety and compliance with EHS guidelines.
