Posted:2 hours ago|
Platform:
Work from Office
Full Time
To ensure that all processes, products, and systems meet the required quality standards by
implementing and monitoring the Quality Management System (QMS) in compliance with ISO13485, GMP, and IVD regulatory requirements.
1. Implement, monitor, and maintain the Quality Management System (QMS) in line with
ISO 13485 and other applicable standards.2. Prepare, review, and manage SOPs, quality manuals, work instructions, and controlleddocuments.3. Review and approve batch production records, validation protocols, and quality reports.4. Conduct and coordinate internal audits, supplier audits, and process audits; ensureclosure of deviations, CAPA, and NCRs.5. Manage change control, deviation control, and risk management activities.6. Coordinate management review meetings and maintain related records.7. Ensure training and competency assessment of staff on quality standards and GMP.8. Provide support during regulatory audits and inspections.
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