Ahmed Hassan

Experience

• 

  Egyptian Holding Company for Biological Products and Vaccines

  Jan 2006 - Nov 2015

  • Led a team of 16 members to acquire American Association of Blood Banks (AABB) accreditation for the blood bank. • Authored, executed, and summarized commissioning and qualification protocols for GXP systems including equipment/test instruments, utilities, and processes.• Coordinated investigations, impact assessment and resolution for validation and re-validation nonconformities.• Managed site validation program ensuring timely execution of re-validation requirements through accurate requirements definition and resource planning.• Manage and conduct, on-site quality audits, review documentation, and assess compliance with all applicable SOP’s, processes, and regulations.• Provide assistance and support to plasma field and corporate personnel regarding quality assurance/control compliance issues.• Work closely with plasma regulatory and operations in identifying applicable regulations and requirements concerning policies and procedures.• Compiled the plasma master file (PMF) for the plasma collected by VACSERA's plasma collection centers and ensured all the required scientific data on the quality and safety of the human plasma relevant to the medicines, medical devices, and investigational products that use human plasma in their manufacture; Covering all aspects of the use of plasma, from collection to plasma pool. عرض أقل • Qualified QC laboratories for ISO 17025:2005 certification in collaboration and under the supervision of Egyptian accreditation council.• Conducted first-party audits on internal departments and second-party audits on vendors and suppliers.• Performed product investigations; supervised product dispositions as required, performed root cause analysis of discrepancies and devised corrective/preventive action plans.• Assessed, evaluated, and approved raw materials and final product in accordance with ISO/IEC17025:2005 requirements, predefined specifications and regulatory requirements. عرض أقل

  • Quality Assurance and Validation Manager

    Apr 2012 - Nov 2015

  • QA/QC Specialist

    Jan 2006 - Apr 2012
• 

  As-Salam International Hospial

  Apr 2012 - Jun 2016

  Quality Assurance Officer

  • Established and monitored blood bank QA program; working with blood bank supervisors to plan, and implement QA related activities according to AABB and JCI standards.• Through affected supervisors, monitored, and evaluated HSE practices and procedures.• Created and developed standard operating procedures for blood bank staff.• Coordinated and performed quality assurance system audits of blood bank performance.• Created and delivered training programs to staff to ensure awareness and understanding of quality standards. عرض أقل

• 

  Spectrum Diagnostics

  Apr 2015 - Jun 2016

  Quality Manager

  • Achieved ISO 13485:2012 certification status through the establishment of infrastructure system for organization-wide quality management system functions.• Supervised completion of audit plans, identifying and resolving nonconformities, completing audits, determining system improvements and implementing change.• Validated quality processes by establishing product specifications and quality attributes, documenting evidence, determining operational and performance qualification.• Acted as system owner of site’s validation program; defined and revised procedures to ensure compliance with cGMP, GLP, FDA, EMEA, and local regulatory requirements.• Collaborated technical advice on new equipment and modification to existing equipment to maintain validation/qualification status in a state of control.• Identified, assessed, and mitigated risks according to ISO 14971:2007; escalated key risks and issues. عرض أقل

• 

  Lokma Group

  Jun 2016 - Sept 2018

  QHSE Manager

  • Achieved ISO 9001:2015 certification status through improving, updating, and establishing organization-wide quality management system functions.• Reduced certification costs by 50% through resource planning, budgeting, and negotiating with accredited certification bodies.• Retained ISO 9001:2008, 14001, and 18001 certifications by establishing, implementing and maintaining quality, safety, and environmental management system functions.• Established and executed quality audit plans according to requirements of ISO 9001:2008, ISO 9001:2015, ISO 14001:2004 and OHSAS 18001:2007.• Created and delivered training programs to staff and Subcontractors to ensure awareness and understanding of QHSE standards and relevance to business objectives. عرض أقل

• 

  SEKEM Group

  Sept 2018 - Apr 2020

  Quality Manager

  • Implemented a three-months organization-wide corrective action plan leading to reopening of the factory after 8-month suspension pending Egyptian Ministry of Health approval.• Retained ISO 9001:2015, 14001:2015, ISO/IEC 17025:2017, ISO 13485:2016, and OHSAS 18001:2007 certifications by establishing, implementing and maintaining QHSE management system functions.• Established and executed quality audit plans according to requirements of cGMP, ISO 9001:2015, ISO 14001:2015, ISO/IEC 17025:2017, ISO 13485:2016, and OHSAS 18001:2007.• Established key performance indicators in alignment with company and operational goals; maintained and reported applicable department and system metrics.• Created and delivered training programs to staff to ensure awareness and understanding of QHSE standards and relevance to business objectives.• Acted as "Management Representative" for all facility internal audits during the ISO certification process, GMP and ministry of health inspections.• Implemented customer complaint system and root-cause problem solving that eliminated major customer complaints.• Managed suppliers’ quality program reducing nonconformities as much as 30%.• Created and delivered training programs to staff to ensure awareness and understanding of QHSE standards and relevance to business objectives.• Collaborated technical advice on new equipment and modification to existing equipment to maintain validation/qualification status in a state of control. عرض أقل

• 

  Afri Medical

  Apr 2020 - Mar 2021

  Quality and Regulatory Affairs Manager

  • Retained ISO 13485:2016 certifications and CE marking by establishing, implementing, and maintaining QHSE management system functions.• Established and executed quality audit plans according to requirements of MDD, cGMP, and ISO 13485:2016.• Established key performance indicators in alignment with company and operational goals; maintained and reported applicable department and system metrics.• Created and delivered training programs to staff to ensure awareness and understanding of QHSE standards and relevance to business objectives.• Acted as "Management Representative" for all facility internal audits during the CE marking, ISO certification process, GMP, and Egyptian ministry of health inspections.• Implemented customer complaint system and root-cause problem solving that eliminated major customer complaints.• Managed suppliers’ quality program reducing nonconformities by as much as 35%.• Led the investigations of all incidents and addressed employees to prevent recurrence.• Participated in the follow-up and close-out of corrective actions that arise from operational activities, inspections, or internal/external audits.• Monitoring the day-to-day management of Quality, Health, Safety, and Environmental issues.• Maintained regular and effective liaison with all levels of management in the organization, the clients, and the local HSE authorities.• Determining effective regulatory pathways for a variety of products.• Assessing, approval, and release of communication material (IFU, leaflets, brochures).• Registering of Class I, IIa, and IIb medical devices before they are marketed.• Monitoring legislative environment in relevant markets. عرض أقل

• 

  Kimal

  Mar 2021 - Sept 2023

  Quality Manager

  • Retained ISO 13485:2016 certifications and CE marking by establishing, implementing, and maintaining quality management system functions.• Established and executed quality audit plans according to requirements of MDD, cGMP, and ISO 13485:2016.• Established key performance indicators in alignment with company and operational goals; maintained and reported applicable department and system metrics.• Created and delivered training programs to staff to ensure awareness and understanding of quality standards and relevance to business objectives.• Acted as "Management Representative" for all facility internal audits during the CE marking and ISO certification process.• Implemented customer complaints system and root-cause problem solving that eliminated major customer complaints.• Managed suppliers’ quality program reducing nonconformities by as much as 35%.• Participated in the follow-up and close-out of corrective actions that arise from operational activities, inspections, or internal/external audits.• Assessing, approval, and release of communication material (IFU, leaflets, brochures).• Assisted in registering Class I, IIa, IIb, and Class III medical devices before they are marketed.• Monitoring legislative environment in relevant markets, including but not limited to, USA, EU, UK, MENA, Brasil, and Egypt.• Lead the budget management activities of the department, working with top management and finance on preparation and management of financial planning and analysis activities.• Managed the transformation from EU MDD to EU MDR to include technical files, labeling (IFU, device, and shipping box labeling), biocompatibility, clinical and non-clinical data, standards, CEPs, and CERs. عرض أقل

• 

  AMECATH

  Sept 2023 - now

  QHSE Director