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Validation expert with experience leading CSV/CSA implementations for Life Science companies following FDA 21 CFR Part11/820, EU Annex 11 and GAMP 5 guidelines. Manage the assembly and delivery of relevant documents: Validation Master Plan, URS, FRS, IQ/OQ/PQ qualification protocols, Data Migration, Integration, and reports for computer systems. Adheres to the principles of risk-based Validation.
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Director Of Validation And ComplianceInnovx Solutions Sep 2021 - PresentMontreal, Quebec, Canada- Mentor and develop the internal validation team- Oversight and coordination of validation projects in the regulated space.- Manage the preparation and delivery of validation documents as required by internal process and/or regulatory agencies.- Strategic advisory support to clients regarding validation industry trends and opportunities.- Manage and develop validation training.
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Senior Validation ConsultantEtq Jul 2021 - Sep 2021- Responsible for implementing innovative and effective test designs and assuring appropriate test coverage.- Prepare and ensure appropriate validation deliverables as required by internal process and/or regulatory agencies, coordination of validation projects with customers and internal stakeholders.- Provide validation-related training to customers as needed.- Scope validation projects, coordination of assignments and supporting the improvement of Life Science-related processes and deliverables.- Mentor Junior Validation IC with their role. Support and review their work and documentation. Ensure project documents follow standards, are complete, current, and stored appropriately. - Support and improve processes and validation deliverables for both internal validation and customer services.- Respond to internal questions regarding ETQ validation projects, guidance regarding validation and regulations. - Perform onsite (at customer’s facility) and Web-based validation services for ETQ products. -
Softwar Validation Implementation ConsultantEtq Oct 2016 - Jul 2021Montreal, Canada Area- Implement Validation Projects for Life Science customers QMS.- Provide validation timeline to PSA/PM or IC to create overall Implementation Project Timeline.- Develop Project’s Validation Tasks: Validation Planning, URS, FRS, Risk Analysis, OQ/PQ Test Scripts, Deviations and Reporting.
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Test & Validation SpecialistAverna Apr 2014 - Mar 2015Montreal, Canada Area- Lead the test & validation phase by gathering project’s requirements and planning test execution in order to improve quality standards.- Collaborate with cross-functional departments including FPGA, Software and Algorithm developers to ensure proper requirements coverage.- Increased the project’s reliability by incorporate an automation testing tool to improve the tests execution phase by identifying key tests and relevant user cases.- Manage the project’s issue tracking list and action items to effectively communicate to all departments the progress on risks, tests and requirements coverage and improved the project’s visibility, while addressing key issues and meeting targeted schedules for release. -
Quality Systems AnalystJohnson & Johnson Sep 2011 - Apr 2014Montreal, Canada Area- Responsible for systems administration.- Prepared and improved the NC, CAPA and Internal audits reporting tools for the Quality Systems department.- Developed and executed PQ Test Protocols for CAPA and NC applications. - Site SharePoint administrator for ETQ system. - Managed the standard operating procedures system (GSS) and training system (Compliance Wire). -
Project AnalystHipotecaria Su Casita Aug 2005 - Jan 2011Mexico City Area, Mexico- Interacted with business stakeholders and subject matter experts in order to understand and define their problems and needs.- Project management: monitored costs per projects, analyzed and forecast cash flow of deviations and compared to actuals.- Point person for customer service to corporate clients and handle business development.
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CoordinatorVivesi Nov 2003 - Aug 2005Mexico City
Daniel Cristo Skills
Daniel Cristo Education Details
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Universidad Anahuac Del SurBusiness Administration -
ItamTelecommunications Engineering
Frequently Asked Questions about Daniel Cristo
What company does Daniel Cristo work for?
Daniel Cristo works for Innovx Solutions
What is Daniel Cristo's role at the current company?
Daniel Cristo's current role is Director of Validation and Compliance at InnovX Solutions.
What is Daniel Cristo's email address?
Daniel Cristo's email address is da****@****rna.com
What schools did Daniel Cristo attend?
Daniel Cristo attended Universidad Anahuac Del Sur, Itam.
What skills is Daniel Cristo known for?
Daniel Cristo has skills like Quality Assurance, Business Analysis, Financial Analysis, Data Analysis, Project Coordination, Test Planning, Manual Testing, Test Automation, Data Management, Operating Systems, Agile Testing, Software Testing.
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Daniel Cristo
Greater Hyderabad Area -
Daniël Cristo Penders
Enterprise Architect At Heerema Marine Contractors | Artificial Intelligence Ai MscAmsterdam Area
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