Job Summary

Position - Manufacturing lead

Location - Turbhe, Navi Mumbai

Qualifications

- Education Qualification - MSc, B. Tech, M. Tech, B. Eng, B. Pharm

Responsibilities

- Regulatory Compliance

- Ensure manufacturing operations comply with CDSCO licensing requirements for IVD devices.

- Ensure manufacturing operations meet regulatory requirements.

- Implement and maintain ISO 13485 and ISO 14971 standards for quality management and risk management.

- Maintain audit-ready documentation for inspections and submissions.

- Manufacturing Operations

- Lead daily production activities, ensuring efficiency, safety, production timelines and adherence to SOPs.

- Oversee documentation for batch-wise traceability.

- 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.

- Address CAPA and root cause analysis for deviations.

- Team Leadership

- Train and mentor production staff on GMP, QSR, and MDR requirements.

- Coordinate cross-functional teams (R&D;, QA, Regulatory Affairs)



to align manufacturing with product development.

- Risk & Safety Management

- Implement risk management frameworks per ISO 14971.

- 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 job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Manufacturing Lead (Mumbai)
🏢 HaystackAnalytics
📍 Mumbai