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Amir Ezami

Senior Associate

Amir has over 23 years of  quality assurance and validation experience within pharmaceutical, biological, medical device and cosmetic industries in international arena. He has been an integral part of deployment and implementing of quality management systems.  His expertise includes Facilities , Utilities, and equipment  qualification.   His well versed in Process Validation and CSV.   Amir has managed sites preparation for FDA preapproval inspection.  He managed critical quality related project in support consent decree remediation (six companies)

 

Amir’s worked as Director of quality in BioDuro and  prior to that he was Director of quality at Stallergenes Greer (San Diego).

His experiences includes:

 

  • Develop and implement quality management systems (deviation management,   OOS management, change management, CAPA, documentation management audit, etc.)

  • Production and supply chain management

  • Audit and due diligence

  • Third party audit management and the respective responses and remediations

  • Prepare quality standards, standard operating procedures

  • Batch record review. 

  • Prepared quality plan, quality metrics and annual product review

  • Assisted with FDA 483 respond and remediation activities

  • Managed a wide range of strategically critical projects for companies sanctioned by FDA Consent Decree. (Six companies)

  • Developed and implemented key Quality Systems (e.g., Change Control, Deviations, Complaint Management, CAPA, etc.) and established successful Validation programs utilized by major as well as start-up US and foreign companies.