Experience • 12–18 years of manufacturing operations experience within Medical Devices, Pharmaceuticals, Biologics, or regulated healthcare manufacturing. • Significant experience leading assembly and packaging operations. • Proven experience managing high-performing manufacturing teams in a cGMP-regulated workplace. • Demonstrated success in regulatory inspections and quality systems. • Strong background in Lean Manufacturing, Operational Excellence, and Continuous Improvement. Education • Bachelor's degree in engineering. • Master's degree preferred. Key Responsibilities Manufacturing Operations Leadership • Lead end-to-end assembly and packaging operations for medical devices, ensuring safe, compliant, and efficient manufacturing. • Own daily manufacturing performance with complete accountability for delivery commitments, quality, productivity, and cost. • Drive production planning and execution to ensure optimum utilization of manpower, equipment, materials, and manufacturing capacity. • Ensure quarterly business deliverables and operational KPIs are consistently achieved.
Delivery Excellence & Operational Ownership • Take complete ownership for manufacturing schedules and customer delivery commitments. • Establish and monitor operational KPIs including: o On-Time Delivery o Schedule Adherence o Overall Equipment Effectiveness (OEE) o Productivity o First Pass Yield o Right First Time o Packaging Efficiency o Training Compliance o Quality Metrics • Proactively identify operational risks and implement mitigation plans to ensure uninterrupted supply. Quality, Compliance & GMP Leadership • Champion a strong quality culture through strict adherence to cGMP, GDP, SOPs, and regulatory requirements. • Ensure all manufacturing documentation is accurate, complete, and inspection-ready. • Maintain continuous audit preparedness for internal, customer, and global regulatory inspections. • Ensure compliance with applicable medical device quality standards and regulatory ex
📌 Medical Device (Karnataka)
🏢 BIOCON BIOLOGICS
📍 Karnataka
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