Amira Eadington

About Amira Eadington

Executive Leader in Quality & Compliance with the ability to drive organizational change in Biotech, CDMO, and Pharma industries, expertise spans across Quality, Supply-chain, and Regulatory compliance in US & Europe.Hands-on leader and strategic executive providing a critical role to the Quality organization and Regulatory compliance aligning and achieving company objectives. With over 12+ years of quality expertise and progressive leadership in building and managing of highly effective global teams in quality, continuous improvement, quality control, and compliance.Performed 300+ audits under ISO 9001, ISO 13485, ISO FSSC GMP for the Pharma, food industry, personal care, and medical foods \"food for special medical purposes\" such as clinical nutrition, parenteral nutrition, and lipid emulsion.Experience in auditing facilities that manufacture topical OTC, GMP for cosmetic and ISO, ISO 9001, and FS/GMP for medical food, nutraceuticals, excipients, and suppliers\' specific manufacturing requirements. Experience in auditing manufacturing facilities that perform aseptic manufacturing under sterile conditions for the food, medical and pharmaceutical industries.Experience in medical gas manufacturing medical gases supply systems: Completed more than 90+ ASU air separation facilities audits, carbon dioxide and nitrous oxide manufacturing facilities for the food industry and the medical gases used in hospitals and healthcare facilities (Medical Air, Oxygen, Carbon dioxide, Nitrogen, Nitrous Oxide) under ISO 9001:2015 and FSSC an Engineering Degree and two Masters, Masters of Management focused on Industrial Engineering, Total Quality Management, Environmental Safety and Systems, Amira possess a work experience of over than twelve years that encompasses Quality Assurance, Lean manufacturing and Six Sigma, Food and pharmaceutical Safety Industry Work, cGMP Inspections, Auditing, Consultancy and Tutoring. She worked for several corporations in the consultancy and auditing of management systems. Amira has developed, implemented and maintained various Quality Management systems under ISO 9001, Lean manufacturing, FSSC cGMP, and ISO 13485.Amira worked for various European certification bodies in France and Switzerland (OIC, OCACIA, SGS) as a Lead Quality Assurance Auditor and progressed through training and audit experience to be the Certification Manager and ISO standards technical expert.

Experience

1. Apm - Gmp & Medical Program

   Intertek

   Jan 2024 — Present

Education

• Université Jean Moulin (Lyon III)

  Master's degree, Public Policy (M.S.) Specialization:Regulatory policies to develop and implement government programs

• UC San Diego

  Clinical and Industrial Drug Development

• National Institute of Engineering of Tunis

  Engineering degree, Specialization: process Engineer

  2008

• Université Paris-Est Marne-la-Vallée

  Master's degree, Total Quality Management, Environment Safety & Systems.

Skills

• Food Safety Management System
• Iso 22000 – Fssc 22000 3rd Party Lead Auditor
• Quality Management
• Lean Management
• Lean Manufacturing
• Quality Control
• Consumer Product Safety
• Management of Change
• Six Sigma
• Quality Auditing
• Management
• Process Engineering
• Haccp
• Quality System
• Quality Assurance
• Iso
• Total Quality Management
• Iso 9001 3rd Party Lead Auditor
• Iso 9000
• Business Process Improvement
• Tqm
• Food Safety
• Iso 22000
• Training