נדיה פיקס

QMS Advisor
• Quality Management System Maintenance in compliance with internal standards and regulations
• Knowledge of 21 CFR part 820 and ISO 13485
• Site Management Representative in external and internal QMS audits and inspections
• Submitting of technical documentation
• Management of quality documents (procedures, protocols, reports, work instructions, records)
• Non-conformities and CAPA management
• Change control management
• Batch release process
• Employees training
• Risk management implementation
• Management Review preparation