Job Description Experiencen • 12–18 years of manufacturing operations experience within Medical Devices, Pharmaceuticals, Biologics, or regulated healthcare manufacturing.n • Significant experience leading assembly and packaging operations.n • Proven experience managing high-performing manufacturing teams in a cGMP-regulated environment.n • Demonstrated success in regulatory inspections and quality systems.n • Robust background in Lean Manufacturing, Operational Excellence, and Continuous Improvement.n Educationn • Bachelor's degree in engineering.n • Master's degree preferred.n Key Responsibilitiesn Manufacturing Operations Leadershipn • Lead end-to-end assembly and packaging operations for medical devices, ensuring safe, compliant, and efficient manufacturing.n • Own daily manufacturing performance with complete accountability for delivery commitments, quality, productivity, and cost.n • Drive production planning and execution to ensure optimum utilization of manpower, equipment, materials, and manufacturing capacity.n • Ensure quarterly business deliverables and operational KPIs are consistently achieved.n Delivery Excellence & Operational Ownershipn • Take complete ownership for manufacturing schedules and customer delivery commitments.n • Establish and monitor operational KPIs including:n o On-Time Deliveryn o Schedule Adherencen o Overall Equipment Effectiveness (OEE)n o Productivityn o First Pass Yieldn o Right First Timen o Packaging Efficiencyn o Training Compliancen o Quality Metricsn • Proactively identify operational risks and implement mitigation plans to ensure uninterrupted supply.n Quality, Compliance & GMP Leadershipn • Champion a strong quality culture through strict adherence to cGMP, GDP, SOPs, and regulatory requirements.n • Ensure all manufacturing documentation is accurate, complete, and inspection-ready.n • Maintain continuous audit preparedness for internal, customer, and global regulatory inspections.n • Ensure compliance with applicable medical device quality standards and regulatory expectations.n • Promote "Quality First" and "Right First Time" manufacturing practices across the organization.n Process Excellence & Continuous Improvementn • Drive continuous improvement initiatives focused on:n o Defect reductionn o Cycle time improvementn o Cost optimizationn o Productivity enhancementn o Waste eliminationn o Process standardizationn • Conduct process capability analysis for development and commercial products.n • Recommend and implement improvements in manufacturing processes, equipment, layouts, and workflows.n • Lead verification and validation activities for process changes where applicable.n Cross Functional Collaborationn • Work closely with:n o Engineering & Maintenancen o Quality Assurancen o Quality Controln o Supply Chainn o Warehousen o Validationn o Regulatory Affairsn o Manufacturing Science & Technology (MSAT)n • Ensure timely closure of cross-functional actions impacting manufacturing performance.n • Support product transfers, process improvements, equipment qualification, and new product introductions.

📌 Medical Device & Packing Operations (Vasanthanagar)
🏢 BIOCON BIOLOGICS
📍 Vasanthanagar