Khaled Ahmed Ahmed

Africa QA LeadFull Time

• Job Details:1. Manage and maintain Quality Management System of the Organization (ISO 9001:2015 & ISO 13486:2016). 2. Development and maintenance of the region Quality Management System (QMS) to assure product quality and safety. 3. Conduct periodically regional QMS and metrics reviews with region top management. 4. Coach and mentor functional teams on the development, maintenance and simplification of local procedures. 5. Provide advice and counsel to business managers in North & East Africa region. 6. Plan and execute internal/external audits and implementation of CAPAs to address non-conformances. 7. Lead and support continuous improvement activities (Standards compliance, Risk management, and metrics development / implementation). 8. Recruit, mentor, coach and train direct and indirect reports, as well as distributors on Quality Specific Goals. 9. Manage and monitor implementation of Good Distribution Practice (GDP) in GEHC warehouse or 3rd parties. 10. Interface with Supplier Quality Team to ensure approval and use of qualified QMS relevant 3rd party suppliers. 11. Identify and report any quality or compliance concerns and take immediate corrective action as required. 12. Timely closure of customer complaints, field actions, and quality system non-conformances.

Deputy Site DirectorFull Time

• Job Details:1. Manage & Maintain Quality Management System of the Organization (ISO 9001:2015). 2. Ensures Health & Safety of Organization through OHSAS 18001 Implementation. 3. Ensure Environment Compliance through ISO 14001 Implementation. 4. Liaise with all key stakeholders to ensure all Management Systems are adhered as per policies and procedures of the organization and Management System. 5. Lead Organization’s Internal Audits for Quality & other Management System 6. Manage the development and implementation of Regulatory strategies and plans to support the timely introduction of new products and the preparation and review of government submissions to achieve timely and cost effective. 7. Monitors and assesses Regulatory developments related to the Company’s products according to SFDA guidelines. 8. Reviews product labeling to ensure conformance with Regulatory requirements and / or approved product claims. 9. Deliver relevant protocols for Method transfer, Production Batch records, Packaging Batch record, QC analytical methods, Analytical Method validation, Cleaning Validation and process validation protocols. 10. Review and update Product specifications, Analytical testing methods, Active Pharmaceutical Ingredients and Inactive ingredients Specifications and testing method in compliance with Arabio specifications. 11. Assess the contract Manufacturer manufacturing and packaging process to be complying with Arabio Specifications. 12. Act as Local Change liaison for technical issues. 13. Review compliance status of the contract manufacturers: 14. Randomly attend the production process, randomly review batch manufacturing records. 15. Review and evaluate Packaging materials supplier and other service provider selected by the contract manufacturer. 16. Participate with contract manufacturers' investigations for complaints of locally manufactured products. 17. Liaising between Contract Manufacturer and RM/PM suppliers to establish QAA. Greatest successes achieved are: 1. Complete registration files & technical transfer project for packaging of GSK, Novartis, Janssen and AbbVie vaccines. 2. Successful Start up of sterile formulation, filling & lyophilizing of vials and Pre-filled Syringe.

Production Section Head / TPM CoordinatorFull Time

• Job Details:Develop the production budget, strategies, based on the sales forecast and aligned with the company goals. 1. Technical support for Third Party Manufacturer (TPM) of Solid dosage form (Tablets & Capsules) & suspension for product transfer and problem solving for validation activities. 2. Ensure good forecasting for materials & manpower requirements and in the developing of the production schedule according to customer orders and annual demand. 3. Managed a team (production supervisors & Technicians) that working in Solids (Dry and wet granulation, compression, coating), semi-solids production and packaging lines. 4. Technology transfer team member in solid oral, semi-solids and sterile form (from pilot scale to production scale). 5. Participated in factory acceptance tests (FAT) and site acceptance test (SAT) in solid dosage forms (fluid bed dryer , shear mixer , film & sugar coating system , Tablet compression machines). 6. Managing pharmaceutical operations based on increasing overall equipment effectiveness (OEE). 7. Successfully launched a Quality objective (increasing productivity by 25% & yield by 2%) based on six sigma methodology. 8. Responsible for pharmaceutical training courses in cGMP, process Validation, CAPA and documentation control. 9. Ensuring the efficient manufacturing of products with respect to capacity volumes, time, costs and product specifications. 10. Responsible for implementing safety policies and standards to secure personnel and safeguarding machinery. Greatest successes achieved are: 1. Complete project to transfer 2 semi-solids lines (creams, ointment and suppository) from El Salam to Giza site. 2. Complete technical transfer project of Solids (Tablets & Capsule), Suspension and sterile powder filling with third party manufacturer. 3. Managing a team to decrease manual operation to semi-automatic (From 80 % to 15% only).