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.

- Team-oriented leadership with focus on public health impact.

Disclaimer: This has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

📌 Manufacturing Lead (Mumbai)
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