Suany Ftima Galvez Villa Email & Phone Number | 24 years of experience working in the Pharmaceutical industry. 12 years of experience as Quality Assurance Auditor Quality Assurance experience includes: Good Clinical Practice - Perform QA audits of clinical trial data and records in Latam, in order to assure compliance with CRO or Clients SOPs, study protocols, Good Clinical Practice guidelines, and relevant regulations. - CAPA management resulting from Client audits from the Americas and from several EU. Follow up on the completion of CAPAs - Host external audits and inspections - Support operational team on Regulatory Inspections. Experience include having FDA, MHRA, PMDA, Health Canada and regulatory authorities from Latam - Inspection Readiness Activities 4 publications Languages: Spanish (Native Language), English (Advance), French (Elementary) Hosting external audits and inspections of ICON and site inspection management. Management of CAPA resulting from all external audits to ICON in Americas (US and Latam) and EU and follow up until completion. To collaborate with the responsible Functional Leads for each response to ensure robust root cause analysis as well as associated corrective and preventive actions are identified and provide appropriate feedback/comments prior to finalization of the responses/CAPAs. Additionally, responsible for returning the audit responses to the clients and providing regular updates on the status of the CAPAs as well as the associated evidence through to closure. Support operational team on Inspection Readiness Activities as well support on Regulatory Inspections (RA: FDA, MHRA, PMDA, Health Canada and regulatory authorities from Latam)

Suany Ftima Galvez Villa

24 years of experience working in the Pharmaceutical industry. 12 years of experience as Quality As...
Mexico

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Suany Ftima Galvez Villa’s Email suany.villa@iconplc.com

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Suany Ftima Galvez Villa’s Location Mexico

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Suany Ftima Galvez Villa’s Prior Industry Icon Clinical Research | Mds Pharma Services | Cencec

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Work Experience

Icon

Principal Auditor Quality & Compliance, Icon Clinical Research Mexico Sa De Cv

2022-04-01 00:00:00 - Present

Icon Clinical Research

Sr Qa Auditor Quality And Compliance

2015-04-01 00:00:00 - 2022-04-01 00:00:00

Mds Pharma Services

Cra Ii

2004-01-01 00:00:00 - 2007-01-01 00:00:00

Cencec

Cra

1998-01-01 00:00:00 - 2002-01-01 00:00:00

Skills

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FAQ About Suany Ftima Galvez Villa

Suany Ftima Galvez Villa is located at
Mexico

Suany Ftima Galvez Villa is a 24 years of experience working in the Pharmaceutical industry. 12 years of experience as Quality Assurance Auditor Quality Assurance experience includes: Good Clinical Practice - Perform QA audits of clinical trial data and records in Latam, in order to assure compliance with CRO or Clients SOPs, study protocols, Good Clinical Practice guidelines, and relevant regulations. - CAPA management resulting from Client audits from the Americas and from several EU. Follow up on the completion of CAPAs - Host external audits and inspections - Support operational team on Regulatory Inspections. Experience include having FDA, MHRA, PMDA, Health Canada and regulatory authorities from Latam - Inspection Readiness Activities 4 publications Languages: Spanish (Native Language), English (Advance), French (Elementary) Hosting external audits and inspections of ICON and site inspection management. Management of CAPA resulting from all external audits to ICON in Americas (US and Latam) and EU and follow up until completion. To collaborate with the responsible Functional Leads for each response to ensure robust root cause analysis as well as associated corrective and preventive actions are identified and provide appropriate feedback/comments prior to finalization of the responses/CAPAs. Additionally, responsible for returning the audit responses to the clients and providing regular updates on the status of the CAPAs as well as the associated evidence through to closure. Support operational team on Inspection Readiness Activities as well support on Regulatory Inspections (RA: FDA, MHRA, PMDA, Health Canada and regulatory authorities from Latam)