Peter Nagy Sheath

Quality ManagerFull Time

• Job Details:1. Rsponsible for development, implementation and monitoring of the Quality System. ISO 9001: 2015, ISO 45001: 2018, ISO 14001: 2015. 2.Review Quality agreements with external partners suppliers. 3.Manage quality processes and reports - suspect products, damage products Recall, complaints Maintain relationships with suppliers. 4.Manage and implement requirements from Suppliers, customer and internal sources as input for new process or problem solving. 5.Contribute to new business initiatives and projects, and communicate the impact on Quality Management Systems and GSP, GDP. 6.Work as part of the Management team to improve operations and ERP system. 7.Develop and deploy a standardized inventory handling and control process across all locations and ensure the effectiveness of the implementation. 8.Create, Manage and monitor a measurement for process and review of internal processes, that affect the quality management system and GSP, GDP. 9.Update documented information described in the Quality Management System and communicate to carry forward lessons learned from quality concerns. 10.Report to top management on the performance of the IMS , GSP, GDP including the need for improvement. 11.Monitor, create and report on Key Performance Indicators (KPI's) for each Area Ensuring that are met. 12.Using six sigma and lean six sigma as an improvement tool besides statistical analysis for the performance of the process using Statistical tools. 13.Train in all aspects of the quality system, and application of procedures. 14.Liaise with external bodies on all matters relating to registration and recertification for ISO 9001, 14001, 45001and supplier visits. 15.Ensure that all documented information are updated, revised and modified to meet the needs of GSP, GDP regulation, external certification bodies and Verify closure of non-conformities with Certification Bodies. 16.Conduct risk assessments of all processes.

Quality System ManagerFull Time

• Job Details:1. Contribute to the creation and implementation of best practice capacity planning vision, functional strategy, policies, processes and documented information to aid and improve operational performance. 2. Contribute to new business initiatives and projects, and communicate the impact on Quality Management Systems and GMP. 3. Design Quality Processes throughout the manufacturing operation, and monitoring the quality performance and GMP. 4. Create, Manage and monitor a measurement for both process and product, and review of internal processes, especially those that affect the quality management system and GMP. 5. Update documented information described in the Quality Management System 6. and communicate to carry forward lessons learned from quality concerns. 7. Report to top management on the performance of the QMS (e.g., results of quality audits, corrective actions), GMP including the need for improvement. 8. Monitor, create and report on Key Performance Indicators (KPI's) for each Area Ensuring that are met by working to the overall plan, including management. 9. Using six sigma and lean six sigma as an improvement tool. 10. Responsible for continuous improvement and updating SOPs for all process. 11. Keep up on new standards, regulations/laws, issues, GMP and news respect to product quality. 12. Lead auditor for ISO 9001, 14001and 45001. 13. Train others in all aspects of the quality system, and application of procedures. 14. Liaise with external bodies on all matters relating to registration and recertification for ISO 9001, 14001, 45001. 15. Ensure that all documented information are updated, revised and modified to meet the needs of GMP regulation, external certification bodies and Verify closure of non-conformities with Certification Bodies. 16. Ensure that all necessary systems and documented information are in place to satisfy all customer requirements and audits. 17. Provide detailed statistical analysis for the performance of the process using Statistical tools (control chart, Pareto, trend analysis R&R gage…etc.) 18. Ensure that the function operates in accordance with any health, safety and environmental policies and procedures. 19. Conduct risk assessments of all processes. 20. Work as part of the Management team to share ideas and improve operations and ERP system.

Quality Assurance ManagerFull Time

• Job Details:1. Create QHSE Objectives according to external and internal polices, follow up action plans to maintain the continuous improvements. 2. Create and update SOP and work instructions for QHSE, GMP. 3. Established key process indicators (KPI’s) and implemented CAPA to eliminate the root causes of poor quality and delivery problems. 4. Implement, Communicate and Follow up the GMP and QHSE requirements through KPIs. 5. Monitoring daily performance for QHSE by gathering relevant data and producing statistical reports. 6. Conduct GMP and HSE training in a daily bases according to training plan for different levels supported by On Job Training. 7. Implement, maintain and follow up the management review. 8. Develop, implement and maintain audit plan to conduct internal audits according to ISO 9001, 14001, ISO 45001 and GMP. 9. Lead the surveillance audit from external vendors and regulatory visits as a quality representative and following up the actions. 10. Vendor evaluation and qualification for packing and raw materials. 11. Prepare daily, monthly and yearly reports about the status of GMP, QHSE overall department contain the needs for improvement. 12. Develop, implement and maintain OQ and PQ protocols for devices and machines. 13. Create and update Site Master File and Validation Master Plan. 14. Implement, maintain process, cleaning validation and Hold time for different products. 15. Monitor, maintain Area qualification including HVAC. 16. Conduct risk assessment in daily basis for every place and implement an action plans for every issue. 17. Prepare calibration plan (External and Internal calibration plan). 18. Create, review and release Master Batch record. 19. Preparation of Annual Product Review. 20. Handling of Market complaints and out of specification.