01 Aug
|
BIOCON BIOLOGICS
|
Vasanthanagar
01 Aug
BIOCON BIOLOGICS
Vasanthanagar
Job DescriptionExperience N
- 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 inregulatory inspections and quality systems. N
- Strong background in Lean Manufacturing, Operational Excellence, and Continuous Improvement. NEducationn
- Bachelor's degree in engineering. N
- Master's degree preferred. NKey ResponsibilitiesnManufacturing Operations Leadership N
- Lead end-to-end assembly and packaging operations for medical devices, ensuring protected, compliant, and efficient manufacturing. N
- Own daily manufacturingperformance 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. NDelivery Excellence & Operational Ownership N
- Take complete ownershipfor manufacturing schedules and customer delivery commitments. N
- Establish and monitor operational KPIs including: No On-Time Deliveryno Schedule Adherence No Overall Equipment Effectiveness (OEE) No Productivityno First Pass Yield No Right First Timeno Packaging Efficiency No Training Complianceno Quality Metrics N
- Proactively identify operational risks and implement mitigation plans to ensure uninterrupted supply. NQuality, Compliance & GMPLeadership N
- 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. NProcess Excellence & Continuous Improvement N
- Drive continuous improvement initiatives focused on: No Defect reductionno Cycle time improvement No Cost optimizationno Productivity enhancement No Waste eliminationno Process standardization N
- Conduct process capability analysis for development and commercial products. N
- Recommend and implementimprovements in manufacturing processes, equipment, layouts, and workflows. N
- Lead verification and validation activities for process changes where applicable. NCross Functional Collaboration N
- Work closely with: No Engineering & Maintenance No Quality Assuranceno Quality Control No Supply Chainno Warehouse No Validationno Regulatory Affairs No 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