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Babujhi SaspaanithyBS

Babujhi Saspaanithy

Information System Engineer (Veeva, QMS, LIMS)

€550/day
Paris, FR
3-7 years

Average response time: 1 hour

Freelancer profile translated to English.
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About Babujhi

Master's degree in Biotechnology and Computer Science. I was a Business System Owner at Sanofi and subsequently an IT Veeva Product Owner at Ipsen. I have solid knowledge in information system validation and configuration of SaaS solutions like Veeva Vault.
  • French

    Native or bilingual

  • Tamil

    Native or bilingual

  • English

    Fluent

Can work on-site
Paris (up to 20km)

Experience

  • Servier
    Business Expert
    PHARMACEUTICALS INDUSTRY
    August 2023 - Today (2 years and 10 months)
    Saclay, France
  • IPSEN
    IT Veeva Product Owner
    PHARMACEUTICALS INDUSTRY
    May 2022 - May 2023 (1 year)
    92100 Boulogne-Billancourt, France
    Activities performed as IT Veeva Product Owner:

    - Management of the Veeva Vault platform. (Promomat, Platform, QualityDoc, RIM, eTMF)
    - Management of Veeva releases (Impact analysis, communication on new features, CABs, regression testing management)
    - Implementation of new features based on business requirements (CDN link, Glossary, Collaborative Authoring Tool, Reports and Dashboards)
    - Non-compliance management.
    - Monitoring activities related to change implementation (execution of qualification and operational qualification installations)
    - Analysis of data extraction and migration.
  • SANOFI
    Business System Owner
    PHARMACEUTICALS INDUSTRY
    October 2019 - October 2021 (2 years)
    94250 Gentilly, France
    [Caduceum Consultant]
    Full-time at Sanofi as Business System Owner for the Change Control module on the Phénix QMS.

    My activities include:
    - Training and Execution of the PUMA methodology
    - Management of "change control" type records
    - User access review and management.
    - Drafting, review, and execution of test cases
    - Management of evolution requests and corrective requests for Phénix (Quality Management System).
    - Communication and support for Phénix tool users.
    - Drafting quality processes (audit trail review, data updates management, data integrity).
    - Backup for managing Event & CAPA and QRM modules of the Phénix tool.
    - Management of tools like SharePoint, ServiceNow, Redmine
    - Management of system Quality documents and use of DMS (Document Management System) storage tools
    - Management of the quality of communication between QMS (Quality Management System) and ERP via web services. Project:
    - Drafting User Requirements for the implementation of a global quality management system.
    - Functional specifications development
    - Study of the "change control" process and its impact on batch release.
    - Quality management of the Change Control module migration (tool: Phénix)

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Education

  • Gphy, Master's in Physiological, Biotechnological, and Computer Engineering
    University of Poitiers
    2018
    Gphy, Master Génie Physiologique, Biotechnologique et Informatique
  • Bachelor of Science in Life Sciences (option: bioinformatics), Biology, Computer Science
    University of Poitiers
    2016
    Licence Science de la Vie (option: bio-informatique), Biologie, Informatique

Certifications

Skill set (18)

Categories