Job DescriptionPosition: Lead Medical Device & Packing Operations

NExperience

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- 12–18 years of manufacturing operations experience within Medical Devices, Pharmaceuticals, Biologics, or regulated healthcare manufacturing.
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- Significant experience leading assembly and packaging operations.
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- Proven experience managing high-performing manufacturing teams in a cGMP-regulated environment.
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- Demonstrated success inregulatory inspections and quality systems.
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- Robust background in Lean Manufacturing, Operational Excellence, and Continuous Improvement.
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nEducation

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- Bachelor's degree in engineering.
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- Master's degree preferred.
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nKey Responsibilities

NManufacturing Operations Leadership

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- Lead end-to-end assembly and packaging operations for medical devices, ensuring safe, compliant, and efficient manufacturing.
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- Own daily manufacturingperformance with complete accountability for delivery commitments, quality, productivity, and cost.
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- Drive production planning and execution to ensure optimum utilization of manpower, equipment, materials, and manufacturing capacity.
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- Ensure quarterly business deliverables and operational KPIs are consistently achieved.
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nDelivery Excellence & Operational Ownership

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- Take complete ownership for manufacturing schedules and customer delivery commitments.
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- Establish and monitor operational KPIs including:
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no On-Time Delivery

No Schedule Adherence

no Overall Equipment Effectiveness (OEE)

No Productivity

no First Pass Yield

No Right First Time

no Packaging Efficiency

No Training Compliance

no Quality Metrics





N- Proactively identify operational risks and implement mitigation plans to ensure uninterrupted supply.

NQuality, Compliance & GMPLeadership

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- Champion a strongquality culture through strict adherence to cGMP, GDP, SOPs, and regulatory requirements.
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- Ensure all manufacturing documentation is accurate, complete, and inspection-ready.
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- Maintain continuous audit preparedness for internal, customer, and global regulatory inspections.
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- Ensure compliance with applicable medical device quality standards and regulatory expectations.
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- Promote "Quality First"and "Right First Time" manufacturing practices across the organization.
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nProcess Excellence& Continuous Improvement

N- Drive continuous improvement initiatives focused on:

No Defect reduction

no Cycle time improvement

No Cost optimization

no Productivity enhancement

No Waste elimination

no Process standardization

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- Conduct process capability analysis for development and commercial products.
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- Recommend and implementimprovements in manufacturing processes, equipment, layouts, and workflows.
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- Lead verification and validation activities for process changes where applicable.
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nCross Functional Collaboration

N- Work closely with:

No Engineering & Maintenance

No Quality Assurance

no Quality Control

No Supply Chain

no Warehouse

No Validation

no Regulatory Affairs

No Manufacturing Science &Technology; (MSAT)

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- Ensure timely closure of cross-functional actions impacting manufacturing performance.
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- Support product transfers, process improvements, equipment qualification, and new product introductions.
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📌 Lead Medical Device & Packing Operations (Karnataka)
🏢 BIOCON BIOLOGICS
📍 Karnataka