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Quality manager

Location:
Cairo, Cairo Governorate, Egypt
Posted:
November 11, 2017

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Ahmed Hassan, B.Sc.

Quality Assurance Manager

(002) ***-****-3332

ac29eu@r.postjobfree.com

Cairo, Egypt

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

Summary

Quality manager with 15+ years of progressive experience in fields of Quality Assurance/Quality Control (QA/QC), Occupational Health, Safety and Environmental Control (HSE). 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

Validation

ISO 9001:2015 QMS

ISO 9001:2008 QMS

ISO 14001:2004 EMS

OHSAS 18001:2007 SMS

ISO 17025:2005 QMS

ISO 13485:2012 QMS

Risk Management

Statistical Process Control

Corrective/Preventive Actions

CE marking; European IVDD

GMP/GLP

OH&S

Experience

Quality Manager, 6/2016 – Present

Amiantit Fiberglass Egypt, S.A.E.

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 staff 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 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.

Quality Assurance Officer, 4/2012 – 6/2016

As-Salam International Hospital

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.

Developed standard operating procedures for blood bank staff.

Developed and presented training programs for blood bank staff.

Coordinated and performed quality assurance system audits of blood bank performance.

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 blood bank.

Managed site validation program ensuring timely execution of re-validation requirements through accurate requirements definition and resource planning.

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.

Acted as system owner of site’s validation program; defined and revised procedures to ensure compliance with cGMP, GLP, FDA and local regulatory requirements.

Established key performance indicators in alignment with company and operational goals; maintained and reported applicable department and system metrics.

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 operational risks; escalated key risks and issues.

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 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.

Education and Certification

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

Fundamentals of Health, Safety, and Environmental Control; AUC, 2017.

OSHA General Industry Safety and Health Training (30 hours); AUC, 2017.

Risk Management, Job Hazard Analysis, and HAZOP Studies; AUC, 2017.

IRCA certified lead auditor, QMS ISO 9001:2015. Registration No. 3517 5308 01, 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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