Ahmed Hassan, BSc, TQM, Lead Auditor

Quality Assurance Manager

002***********

ac93qb@r.postjobfree.com

Cairo, Egypt

https://www.linkedin.com/in/AhmedHassanBSc

Summary

Quality Assurance manager with more than 17 years of progressive experience in fields of Quality Assurance/Quality Control (QA/QC), Occupational Health, Safety (OH&S) and Environmental Control. Highly efficient and methodical with considerable experience of developing and implementing quality management processes and systems in manufacturing and corporate environment; successfully contributed to project management, process continuous improvement, business analysis/evaluation, product development lifecycle methodologies, and supplier management.

Areas of Expertise

Quality Management

Quality Auditing

Quality Control

Regulatory requirements

Continual Improvement

Training

ISO 9001:2015 QMS

ISO 14001:2015 EMS

OHSAS 18001:2007 SMS

ISO 17025:2017 QMS

ISO 13485:2016 QMS

Risk Management

Statistical Process Control

Corrective/Preventive Actions

Validation

GMP

GLP

HSE

Experience

Quality Manager, 9/2018 – Present

Atos Pharma, Sekem Holding.

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.

Quality Manager, 6/2016 – 9/2018

Amiantit Fiberglass Egypt, S.A.E.

Achieved ISO 9001:2015, 14001:2004, and OHSAS 18001:2007 certification status through improving, updating, and establishing QHSE management system functions.

Reduced certification costs by 50% through resource planning, budgeting, and negotiating with accredited certification bodies.

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.

Quality Manager, 4/2015 – 6/2016

Spectrum Diagnostics, S.A.E.

Achieved ISO 13485:2012 certification status through the establishment of an 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.

Identified, assessed, and mitigated risks according to ISO 14971:2007; escalated key risks/issues and collaborated corrective/preventive action plans.

Quality Assurance and Validation Manager, 4/2012 – 11/2015

Egyptian Holding Company for Biological Products and Vaccines

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.

QA/QC Specialist, 1/2006 – 4/2012

Egyptian Holding Company for Biological Products and Vaccines

Qualified QC laboratories for ISO 17025:2005 certification in collaboration and under the supervision of the 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.

Education and Certification

Occupational Health, Safety and Environmental Control (HSE) Diploma; American University in Cairo (AUC), 2017.

IRCA certified lead auditor, QMS ISO 9001:2015. Registration No. 351*-****-**, 2016.

Total Quality Management (TQM) Diploma; Cairo University, 2010.

Bachelor of Science (B.Sc.), Biochemistry, Faculty of Science, Ain Shams University, 2002.

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