Skills

• Skilled in computer system validation and risk management throughout the whole SDLC
• Proficient in documentation preparation, validation execution and testing
• Skillful in maintaining system in validated state
• Familiar with waterfall and agile methodology
• Expirience in Change and Risk Management
• Guidance and Regulations: GxP, GAMP 5, Annex 11, 21 CFR part 11, ISO 9001, 21 CFR part 820

Computer skils

Micro Focus ALM and JIRA
EDMS - Windchill and Documentum
ITSM - ServiceNow and HP SM
SAP, SalesForce
MS Office, Office 365, MS Project, Visio Professional, SharePoint
MindManager Enterprise

Refrences

Company: HUXLEY, BARCELONA, SPAIN 2020 – Up to now

Position: Freelance CSV Consultor at Esteve Química

• In charge of validation activities resulted as an outcome of the Laboratory Computerized Systems Change Control Requests for SDMS, CDS, and LCS subsystems D and E.
• SAP OQ test revision and execution as part of “Bing-Bang” implementation
• SAP rollout project
• SAP data migration verification
• Data Integrity Assessment
• Defect management and solution testing
• Bussines Process Flows diagrams
• Infrastructure Risk Assessment

NEXTLINK SOLUTION, BARCELONA, SPAIN 2017-2019

IT Quality Specialist

• Guide stakeholders so that the projects/changes results in a system that is/stayed in validated state by creation/maintain documentation, end user training, and meeting regulatory expectations
• Assure effective application of organization's Quality Management process to the project.
• Defined all necessary System Life Cycle deliverables and confirm it has been produced according to PMM and/or Change Management Methodology
• Coached and trained end users in Change Management and Application Lifecycle Management
• Control that the Change Management process was done according to written procedures/guidance
• Increased efficiency of Change Management approval process by monitoring KPI s/Operational metrics and creation of Dashboard in SreviceNow.

AMARIS CONSULTING, BARCELONA, SPAIN 2015-2017

Computer System Validation consultant at Boehringer Ingelheim

• Analyzed current state of IT Infrastructure documentation and report all found.
• Coached Validation Managers in Change Management Process.
• Trained stakeholders in SDLC Documents guidance for Non-GxP Infrastructure systems.
• Improved Retirement Plan template by incorporating Risk Assessment.

AMARIS CONSULTING, BARCELONA, SPAIN 2014-2015

Computer System Validation consultant at Grifols

• Assured that risk of newly SAP functionalities are analyzed and risk mitigated before implementation.
• Improved verification process of Customizing and Workbench transport requests throughout SAP landscape.
• Created, Reviewed or Approved VMP, VP, IQ, OQ and PQ protocols and corresponding reports, test execution and evidence collection.

Time and Spatial Flexiblity

CS

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