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Highly skilled and accomplished professional with a Master's degree in Chemistry and over 13 years of extensive experience in the field of GxP software's and Lab Digitalization and QMS activities. Utilizes strong technical expertise to optimize laboratory operations and streamline processes. Demonstrates a proven track record of implementing and managing GxP systems, resulting in improved efficiency, accuracy, and compliance.

    8 Years of Experience: In software design, development, business analysis, ITIL operations, customer service management, and product implementation/support in AWS Cloud (SaaS) and Oracle PL/SQL environments. ITIL Proficiency: Skilled in problem, incident, change, and release management, including patch deployment, major incidents, BCP, recovery planning, migration, go-live, KPI metrics, PIR, and SLA management.    Application Support: Provided 24/7 L1, L2, and L3 support, including triaging tickets, troubleshooting, and coordinating with ServiceDesk/Zendesk teams to ensure timely incident resolution and service restoration. Resolved complex technical issues at L2, liaised with L3 development for problem resolution, and acted as a liaison between customers and engineering, translating technical issues. Reviewed and improved workflows to enhance efficiency and user experience, while responding to customer support tickets with timely and effective solutions. Supported the QA team in validating the resolution of customer-reported issues, ensuring robust fixes and clear communication with customers during investigations.    Complex Application Management: Experience in managing complex applications, conducting impact analysis, system audits, CAPA, security risk assessments, and ensuring data security and quality checks.    Problem-Solving: Strong in root cause analysis, impact assessment, resolving complex incidents, managing escalations, and engaging in project discussions and stakeholder interactions.    Compliance and Validation: Hands-on experience with GxP compliance, AML, GMP processes, 21 CFR, business process flow, data flow diagrams, testing, feedback tracking, and UAT coordination.    Operational Support: Managed hot defect fixes, troubleshooting, enhancements, planned outages, health checks, batch jobs, backups, migrations, system upgrades, and UAT meetings.    Agile Methodology: Applied Scrum/Agile practices, assisted with sprint planning, backlog reviews, Jira user stories, demos, and addressing feedback.    Team Leadership: Led cross-functional teams, managed tickets, vendors, stakeholders, mentored team members, and ensured proper handling and escalation of incidents and service requests.    Documentation and Testing: Documented recurring issues, CI changes, SOPs, prepared test cases, and followed ITSM and QMS processes.    Domain Knowledge: Specialized in Lab applications, LIMS configurations, KYC banking applications, and various lab modules such as sample entry, analysis, inventory, stability study, and ELN.  

Effective project manager with over 7 years' experience in IT industry, skilled in Lab Informatics area with hands on experience of LabVantage LIMS and LabWare LIMS. Experienced in working in GxP relevant projects for over 4 years. Good communication skills and quick analytical thinker being the key characteristics which helps to achieve quick resolutions.

Detail-oriented engineer with a computer science background specializing in computer system validation within regulated pharmaceutical environments. Skilled in system lifecycle management, risk analysis, and validation of enterprise systems including LIMS and BMS. Collaborates effectively with product and process engineering teams to ensure compliance and support complex technical systems.

Mario Jose Lafarga Jimenes

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Máster Oficial - Microbiología

Licenciatura - Bioanálisis

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