Ashwini reddy Kapu

writes the final thesis.

Bis 2023, Technical Analyst, GlaxoSmithKline GSK
Wolfsburg, Germany

Skills

Risiko
Medizinische Forschung
Code
Agile Entwicklung
Support
Changemanagement
Literatur
Technische Analyse
Geschäft
Software-Optimierung
Due Diligence
Risikoanalyse
Wissenschaftliche Publikation
QMS
Wissenschaftliche Forschung
Compliance
Application Management
Klinische Entwicklung
Qualität
Arzneimittelzulassung
GxP
SDLC
Interne Revision
Validation
Microsoft Access
Data Quality
Abnahme-Test
Datenanalyse
data discovery
versioning
Biological assay
cell line
Clinical
MedDRA
stakeholders
SNOMED
Thesaurus
traceability
Instandhaltung
Rezension
Innovation
Ontologie
Test
CAPA
Veränderung
Ethik
Project Management
MS Office
Software Development
Software Development Lifecycle
Agile
Audit
21 cfr part 11
Medical Device Regulation (MDR)
Computer System Validation
Testing
MICROFOCUS ALM
Vendor Management
Stakeholder Management
traceability matrix
Ehrlichkeit
Fehlerfreiheit
Engagement
Auslandserfahrung
Team work
Communication skills

Timeline

Professional experience for Ashwini reddy Kapu

  • 2 years and 1 month, Oct 2021 - Oct 2023

    Technical Analyst

    GlaxoSmithKline GSK

  • 2 years and 1 month, Oct 2021 - Oct 2023

    Business System Owner

    GlaxoSmithKline AG

    I am a diligent and dedicated Computer System Validation (CSV) professional with 8 years of comprehensive experience in pharmaceutical CSV. As a Business System Owner, I have successfully led teams, ensuring alignment with business objectives and driving successful project outcomes. My expertise lies in application management, SDLC documentation, and consistently ensuring compliance within pharma systems, managed internal audits, facilitated CAPA processes.

  • 2 years and 1 month, Oct 2021 - Oct 2023

    Computer System Validation analyst

    GlaxoSmithKline AG

  • 6 years and 3 months, Jul 2015 - Sep 2021

    SENIOR SCIENTIFIC ANALYST

    Molecular Connections Pvt. Ltd.

  • 6 years and 3 months, Jul 2015 - Sep 2021

    SENIOR SCIENTIFIC ANALYST

    Molecular Connections Pvt. Ltd.

Educational background for Ashwini reddy Kapu

  • Current 1 year and 7 months, since Nov 2024

    Master of Public Health

    Arden University

Languages

  • English

    C1 (Fluent)

  • hindi

    C1 (Fluent)

  • kannada

    C1 (Fluent)

  • telugu

    C1 (Fluent)

  • German

    B1-B2 (Good)

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