Manufacturing Lead

Job Details

• Position: Manufacturing Lead
• Location: Navi Mumbai
• Education Qualification: MSc, B. Tech, M. Tech, B. Eng

Responsibilities

• Regulatory Compliance: Ensure manufacturing operations comply with CDSCO licensing requirements for IVD devices.
• Regulatory Compliance: Ensure manufacturing operations meet regulatory requirements.
• Regulatory Compliance: Implement and maintain ISO 13485 and ISO 14971 standards for quality management and risk management.
• Regulatory Compliance: Maintain audit-ready documentation for inspections and submissions.
• Manufacturing Operations: Lead daily production activities, ensuring efficiency, safety, production timelines and adherence to SOPs.
• Manufacturing Operations: Oversee documentation for batch-wise traceability.
• Manufacturing Operations: Manage raw material procurement, in-process controls, and final product release.
• Quality Assurance: Collaborate with QA to ensure validation of processes, equipment, and test methods.
• Quality Assurance: Address CAPA and root cause analysis for deviations.
• Team Leadership: Train and mentor production staff on GMP, QSR, and MDR requirements.
• Team Leadership: Coordinate cross-functional teams (RD, QA, Regulatory Affairs) to align manufacturing with product development.
• Risk Safety Management: Implement risk management frameworks per ISO 14971.
• Risk Safety Management: Ensure workplace safety and adherence to biosafety protocols for handling biological samples.

Requirements

• Bachelor s/Master s degree in Biotechnology, Biomedical Engineering, or related field.
• 5-10 years of experience in IVD manufacturing.
• Strong knowledge of production requirements for IVDs.
• Experience with ISO 13485-certified facilities and regulatory submissions.
• Proven leadership in managing teams and scaling compliant manufacturing operations.

Skills

• Strong documentation skills.
• Ability to operationalize and improve workflows that align with regulatory requirements.
• Collaborative leadership with focus on public health impact.

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