Experience

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  Cindefi

  Sept 2010 - Jun 2012

  Junior researcher

  Internship in research tasks. Culture collection development.Research on enzyme inhibitors, enzymatic activity, protein quantification,production, purification, enzymatic pool visualization by gels.

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  Fundación hospitalaria

  Jul 2012 - Nov 2012

  Auxiliar técnica en esterilizacion

  Assistant sterilization technician / Reception, sterilization and preparation ofhospital supplies. Assembling orders. Stove top steam sterilization and autoclavesterilization. Preparation for sterilization with ethylene oxide.

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  Abbott

  Oct 2012 - Mar 2013

  Qa system

  QA System Specialist / Master file actualization. Management and control of shoporders. International documents validity. Claims receipt, entry system adverseevent and monitoring them until their reconciliation. Local documentation changemanagement. Local files distribution. Final tasks of global documents unificationproject and restriction of BOP’s copies. GMP, IRAM, ISO, ANMAT, FDAmanagement.

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  Cognizant

  Aug 2013 - Aug 2017

  Business Analyst in Back Office for the Sales Force Effectiveness/ International laboratory that provides solutions to their Sales Force trough the management of CRM Oracle platform to in a worldwide level. Base analyst in charge of the Sales Force Effectiveness for Colombia and Ecuador. Customer Service - individual and corporate. Working with the client to implement different strategies in the maintenance of information. Documentation for the client and also for internal use. Training provider to all Sales Force Effectiveness from Brazil, Chile, Colombia, Venezuela, Mexico and Argentina. Training of new APMs for MSD and for internal partners. Configuration for the client, (i.e. assesments). Maintenance of the data base controlling the information input and output. Operator and assistant of the whole region (Central America, Argentina, Colombia, Mexico, Chile and Brazil). Issues resolution trough Remedy toolBusiness support in the operation of the system, executing managerial functions for the maintenance and quality of information for the entire Latin American region. Advice to the client for the viability of the implementation changes in the process, evaluating the viability of the new functions requested for later presentation to the development team. Execution of functional testing for the development team in the changes of existing functionality so as in the new functionalities applied to the system. Show less IT System Validations/ Perform laboratory COTS validation.First level of support, identification of issues and escalation. Identification of risk compliance GMPs-internal / external evaluations, self-audits, review of incidents / problems, and regulatory surveillance. Creation of remediation plans. Establish processes of preparation for inspections and availability to support regulatory audits. Develop action plans and SOP. Update and maintenance of equipment validation. Liaising with MMD, Quality and GTO to ensure proper interpretation of the requirements and implementation of regulatory requirements. Support quality planning activities required for new technologies.Provide IT support for: Identify problems (infrastructure, applications, networks, Shop Floor (SFN), and automation environment). Ensure compliance with policies, procedures, standards and guidelines associated with the development, operation and maintenance. Ensure proper documentation of changes in accordance with GMPs, change control, security and environmental standards. Conduct periodic audits of systems and related procedures revisions. Recommend changes or improvements. Responsible for practice troubleshooting and system documentation during the operation and / or supervision of 3rd party technicians to ensure availability and minimum downtime. Develop and review procedures of the system (system operation, alarm handling problem, system troubleshooting, security and backup/recovery). Provide training for new and revised procedures. Conduct periodic evaluations of the systems according to procedures, including the development of action plans and reports. Change control package tracking documentation (esponsible for obtaining the approval and review of the documents). Comply with all environmental regulations, procedures, training, practice, permit conditions and internal reporting of environmental events. Ability to identify solutions and opportunities. Show less Pfizer Project - PMOPeriodic Review and User Access Review Coordinator.QA/Compliance Analyst. Schedule Periodic and User Access Reviews. ConductKick off Meetings. Coordinate multiple applications/sites PR. Initiate datacollection from leads. Prepare Summary Reports. Update PR Tracking. RequestUser Access list and details, verify, request changes require. Route documents inPDOCS. Auditor assistant. Managing reports, analysis and metrics. QuarterlyReconciliation operations. GMP, FDA management. Show less

  • Merck - MSD Project - Business Analyst in Back Office for the Sales Force Effectiveness

    Sept 2016 - Aug 2017

  • Merck- MSD Project - System Validation

    Apr 2015 - Aug 2016

  • Pfizer Project - QA & Compliance

    Aug 2013 - Mar 2015
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  Merck

  Aug 2017 - now

  GDMS Community managementActive representation of GCDI in all the events involved. Management of internal and external professional networks. New Hires welcome activity. Review of Team building activities for virtual/presential session. Active work to engage commitment from GCDI Argentina team on full activities and proposals from MSD corporate.Diversity & Inclusion (D&I)Complete courses available on the GD&I Learning Resource Center. Attend D&I events and share insights and best practices with others. Ensure my meetings maintain an environment where people feel comfortable engaging in dialogue to gain greater awareness and understanding of their experiences, perspectives and worldviews of others. Leverage INSPIRE to recognize and reward staff for demonstrating behaviors associated with building a diverse and inclusive culture as well as for achieving any target outcomes. Show less Lead CDT Analyst Coordination and support from Quality & Compliance perspective on activities involving drug discovery or drug surveillance process. Provide training sessions to new hire, responsibility to provide guidance, examples, and answer questions across the process. Creation of weekly reports and status monitoring providing last status to Delivery Management team. Project Management back up and SME support of PDAM VC Standards UAT activities. Mentoring for resources and provide guidance to achieve a correct troubleshooting of findings during UAT process. Provide guidance to correct and update specs to obtain requirements expected by users. SR Analyst Lead Assignment, Scripts Peer Review and SR closure notification. Ensure processes are developed and executed consistent with GDMS Standards SOPs and correct documents archival. Maintenance of standard scripts at CDT shared. Assignment of task to the different members of the team by skills and complexity. Co lead UAT VCs standards team, taking care of the VCs Standards Library for Oncology Adoption PDAM 2.0 and provides guidance to PDAM NG. First option for complicated studies with aggressive timelines. SME for Validation Tools and an active supporter for CDPP program. Final documentation peer reviewer for several trials before Go Live. Skills for teaching and mentoring. Organizer and moderator of the monthly CDT COE meeting, which brings together all global CDTs, managers and directors.CDT AnalystCoordination/support from Quality perspective on activities involving drug discovery, drug surveillance process. Follow up of tasks and collaborating as technical and methodological support to the team. Creation of test plans, creation of Test Case. Incident management. Creation of test documents. Strong knowledge on ICH and GCP guideline. Availability to complete activities on propose time and achieve timelines without compromising quality. Weekly Meetings with manager and interdisciplinary teams around the world. Show less

  • GDMS – GCDI-Associate Director - Clinical Data Testing Manager

    May 2022 - now

  • Data Management Specialist

    Aug 2017 - now

  • Data Management Specialist

    Aug 2017 - now