Yunes Alshmmakh Email and Phone Number

• Established and implemented a Quality Management System ISO 9001:2015 within the organization to standardize the processes.• Established and implemented a Quality Management System ISO 13485:2016 within the organization to standardize the processes for Medical Devices Sectors.• Implemented the SOP Re-engineering project to in the warehouse level to ensure efficient processes being carried out in compliance with the international standards, regulatory regulation and our partners requirement.• Established a KPI Dashboard to monitor the main outputs generated from day-day operations.• Maintained the accreditation with the certification body for being in compliance with European Pharmaceutical Good Distribution and Storage Practices and WHO Guidelines.• Successfully managed International Manufacture's Audits e.g. Novo Nordisk, Amgen, BMS, Roche Etc. to build and maintain long-term business relationships and seeking for attracting a new partner.• Implemented Risk Management Strategies at strategic and operational levels to mitigate the impact of risks on the business.• Lead internal audits to evaluate the QMS effectiveness, ERP utilization and risk management.• Measure and Analyze raised non-conformities, external and internal audit findings, KPI's results and complaints to be reported to top management to take the appropriate decision to eliminate the root causes and improve the system.• Support all departments in performing risk analysis and initiate a mitigation action plan, policies and procedures accordingly.• Established semi-automated Validation Master Plan with alerts dashboard to ensure the continual validity of all warehouse components.• Performed external audit for outsourced services such as storage and transportation.

• Train employees for the relevant SOPs according to their job titles to enhance the quality culture.• Participated in incident investigations and prepare root cause analysis (RCA) with identifying corrective and preventive actions using the proper quality tools for process improvement.• Supported all departments and process owners in writing and establishing Polices and Standard Operating Procedures (SOPs).• Participated as internal audit member to evaluate the compliance level of departments against their approved process in place.• Managed document control in the organization to ensure all used documents are approved, updated and controlled.

• In labelling activates, inspected set sample of products for defects, ensuring compliance with design standards. • Reviewed incoming goods against specifications, rejecting inadequate materials, components and finished products. • Supervised product dispatch, verifying finished products met the organization standards. • Monitored temperature of products in storage and transportation. • Implemented necessary corrective measures to improve items safety and integrity. • Reported faults, damages and control check point rejections.