Roles and Responsibilities
1.Quality Assurance & Quality Management System
- Maintain and improve the Quality Management System in compliance with ISO 13485.
- Ensure adherence to quality procedures, SOPs, and documentation across manufacturing operations.
2. Regulatory Compliance
- Ensure manufacturing operations comply with regulatory requirements from authorities such as U.S. Food and Drug Administration, Central Drugs Standard Control Organization, and global regulatory bodies.
Support regulatory submissions and product registrations
3. Quality Control Oversight
- Oversee incoming, in-process and final product inspections.
- Ensure appropriate test methods, acceptance criteria, and quality standards are followed.
4. Audits & Inspections
- Lead and manage external audits (ISO, Auditing bodies, customers, clients)
- Ensure timely closure of audit non-conformities (NCs)
5.CAPA & Non-Conformance Management Management
- Corrective and Preventive Action (CAPA) systems.
- Investigate non-conformities, customer complaints, and deviations
6. Customer Quality Interface
- Act as the primary quality interface for customers.
- Handle customer audits, quality reviews, and complaint investigations.
7. Risk Management
- Ensure implementation of risk management processes as per ISO 14971, and ensure compliance with FMEA.
- Support risk analysis during product development and manufacturing changes.
Patient safety & effectiveness