Andrés Gola Isasi, PMP, CSSBB, RAC

Senior Consultant at PharmaBioServ
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Contact Information
us****@****om
(386) 825-5501
Location
Bilbao-Bilbo, Basque Country, Spain, ES
Languages
  • Spanish Native or bilingual proficiency
  • English Native or bilingual proficiency
Skills

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LinkedIn User

I highly recommend Andres for his expertise in Supplier Quality field, quality agreements, supplier changes, etc. With a swift task promotion and strong connections across functions, he consistently delivers fast and efficient results, ensuring supplier compliance and driving collaborative relationships for successful outcomes.

Nelida Plaza

Excellent technical and management professional, calm, cool and collected individual with high ethical values and management skills

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Credentials

  • Six Sigma Black Belt (CSSBB)
    ASQ - World Headquarters
    Mar, 2020
    - Nov, 2024
  • Project Management Professional (PMP)
    Project Management Institute
    Aug, 2019
    - Nov, 2024
  • Regulatory Affairs Certification (RAC)
    Regulatory Affairs Professionals Society (RAPS)
    Mar, 2023
    - Nov, 2024

Experience

  • PharmaBioServ
    • Puerto Rico
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Senior Consultant
      • Feb 2017 - Present

      Provide support to pharmaceutical, medical devices and biotechnology companies in regulatory compliance, project management, continuous improvement, and technology transfer. Experience with clients in North America, Latin America, Europe, Switzerland, Turkey and Israel. Provide support to pharmaceutical, medical devices and biotechnology companies in regulatory compliance, project management, continuous improvement, and technology transfer. Experience with clients in North America, Latin America, Europe, Switzerland, Turkey and Israel.

  • Omrix Biosurgery Israel
    • Israel
    • Biotechnology Research
    • 200 - 300 Employee
    • Supplier Quality Lead
      • Sep 2018 - Present

      Lead quality oversight and manage relationship with critical suppliers of class III combination products (biological-device) direct materials and components. Contract through PharmaBioServ. Lead quality oversight and manage relationship with critical suppliers of class III combination products (biological-device) direct materials and components. Contract through PharmaBioServ.

  • Unikemia
    • Spain
    • Education Administration Programs
    • 1 - 100 Employee
    • Visiting Professor
      • Jan 2020 - Present

      Design courses structure and methodology, curate content and tutor students on project management, lean manufacturing and six sigma. Design courses structure and methodology, curate content and tutor students on project management, lean manufacturing and six sigma.

  • BD
    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Site Quality Engineering Lead
      • Sep 2015 - Jan 2017

      Managed site-wide quality, validations and process improvement activities and new product la introduction projects.

    • Quality Engineer
      • Sep 2013 - Aug 2015

      Responsible for the compliance of manufacturing activities and batch release of class III medical devices.

  • DePuy Synthes
    • United States
    • Medical Device
    • 700 & Above Employee
    • QA Technology Transfer Engineer
      • Sep 2012 - Aug 2013

      Oversight of process validation, test methods implementation and quality documentation for the introduction of a novel total knee implant system in the manufacturing site. Contract through PharmaBioServ. Oversight of process validation, test methods implementation and quality documentation for the introduction of a novel total knee implant system in the manufacturing site. Contract through PharmaBioServ.

  • Zimmer Biomet
    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Quality Engineer
      • Sep 2011 - Aug 2012

      Align orthopedic implants products specifications and test methods with designs and processes risk analysis. Contract through Goode Compliance International. Align orthopedic implants products specifications and test methods with designs and processes risk analysis. Contract through Goode Compliance International.

  • Bascom Palmer Eye Institute
    • United States
    • Hospitals and Health Care
    • 300 - 400 Employee
    • Graduate Student Research Assistant
      • Sep 2010 - Aug 2011

      Supported the development of an image processing algorithm for calculating the refractive index of the eye’s crystalline lens; key system for future cataract and presbyopia treatments. Supported the development of an image processing algorithm for calculating the refractive index of the eye’s crystalline lens; key system for future cataract and presbyopia treatments.

  • eVIDA Group
    • Spain
    • Research Services
    • 1 - 100 Employee
    • Student Research Assistant
      • Aug 2007 - Jul 2010

      Supported the development of multiple audio and image processing algorithms for voice rehabilitation and melanoma diagnosis, respectively. Supported the development of multiple audio and image processing algorithms for voice rehabilitation and melanoma diagnosis, respectively.

Education

  • University of Miami
    Master of Science, Biomedical Engineering
    2010 - 2012
  • Universidad de Deusto
    Bachelor, Telecommunications Engineering
    2004 - 2009

Community

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