Nour Kandalaft

• · Qualification and validation of analytical laboratory equipment, including IQ/OQ/PQ of HPLC systems and UV-Vis spectrophotometers.

• · Led the migration and validation of Empower software to version 3.8, ensuring data integrity and regulatory compliance.

• · Performed calibration testing, data analysis and deviation investigation.

• · Managed equipment troubleshooting.

• · Supported the maintenance and continuous improvement of QMS in compliance with ISO 13485 and MDR 2017/745 requirements.

• · Reviewed, updated, and maintained QMS procedures, work instructions, and records, ensuring alignment with regulatory and internal standards.

• · Actively participated in internal audits and supplier audits, including preparation, execution support, follow-up, and CAPA implementation.

• · Managed CAPA processes, including root cause analysis, effectiveness checks, and follow-up actions to ensure continuous quality improvement.

• · Handled non-conformities and change control activities, ensuring proper impact assessment and documentation within the QMS.

• · Prepared quality performance reports and indicators, providing transparency on quality metrics and supporting management review activities.

• · Collaborated closely with Production and R&D teams to ensure quality standards were consistently applied across the organization.