15 Aug
|
Menschen Consulting
|
Bareilly
15 Aug
Menschen Consulting
Bareilly
1. Job Purpose
The Head – Manufacturing will be responsible for leading the overall manufacturing and operations function of the IVD business, ensuring capacity, quality, cost, productivity, regulatory compliance, supply reliability and operational excellence .
The role will oversee end-to-end manufacturing operations covering raw-material planning, production, formulation, filling, packaging, quality systems, engineering, maintenance, warehouse, supply chain and plant operations , while ensuring compliance with applicable IVD/medical-device regulatory requirements.
The Head –will work closely with the CEO/MD, R&D;, Quality, Regulatory, Sales & Marketing, Finance and Supply Chain teams to scale the organization and build a high-quality, cost-effective and globally compliant manufacturing operation .
2. Key Responsibilities
A. Manufacturing & Plant Operations
- Lead overall manufacturing operations for medical device /IVD reagents, kits, calibrators, controls and diagnostic products.
- Drive production planning and execution in line with business demand and sales forecasts.
- Ensure achievement of production targets, OTIF delivery, yield and productivity.
- Develop manufacturing capacity plans for current and future business requirements.
- Optimize manpower, machines, production lines and facility utilization.
- Establish standardized manufacturing processes and SOPs.
- Drive reduction in production cycle time, rejection, wastage and batch failures.
- Ensure robust batch manufacturing, filling, labeling and packaging processes.
- Develop scalable manufacturing systems for new product launches.
B. Quality & Regulatory Compliance
- Ensure manufacturing operations comply with applicable IVD, medical-device, GMP and quality-system requirements .
- Work closely with QA/QC and Regulatory Affairs to maintain audit readiness.
- Ensure effective implementation of SOPs, CAPA, deviation, change control and batch-release systems.
- Drive compliance with applicable standards su
📌 Head of Manufacturing operations (Bareilly)
🏢 Menschen Consulting
📍 Bareilly