Rakshitha Venkatesh

Angestellt, Governance, Risk and Compliance Consultant, msg industry advisors ag
Gröbenzell, Germany

Fähigkeiten und Kenntnisse

FDA
Validation
21 CFR Part-11
EU Annex-11
GAMP5
Computer System Validation
Defect/Deviation Management
Good Documentation Practices
Risk management
Change Management
Good Testing Practices
JIRA
ProcedureCapture
HP ALM
SolMan
DIM
DocER
ValGenesis

Werdegang

Berufserfahrung von Rakshitha Venkatesh

  • Current 4 years, since Jul 2022

    Governance, Risk and Compliance Consultant

    msg industry advisors ag
  • 2 years and 7 months, Apr 2019 - Oct 2021

    Test Specialist – Testing (CSV)

    Philips India

    Responsible for review and approve the validation deliverables such as System Change Request, Design Specification, Functional Requirement Specification, User Requirement Specification, Risk Assessment, Test Scripts (IQ, OQ, PQ), Test Executions, Requirement Traceability Matrix, Compliance Plan and Compliance Summary Report in Test Management tool

  • 3 years and 1 month, Dec 2015 - Dec 2018

    Engineer – Quality Assurance (CSV)

    ArisGlobal Software Pvt. Ltd., Mysuru, India

    Planning and implementation of validation processes on various applications to comply FDA 21 CFR Part 11 regulations Review and approve the Validation Deliverables such as User Requirements, Test Scripts, Test Executions, Test Incidents, Requirement Traceability Matrix and Change Controls Authoring Validation Deliverables such as Validation Plan/Protocols, Summary Reports

Ausbildung von Rakshitha Venkatesh

  • 4 years, Aug 2011 - Jul 2015

    Information Science & Engineering

    Visvesvaraya Technological University (VTU)

    Bachelor of Engineering in Information Science & Engineering

Sprachen

  • English

    C1 (Fließend)

  • German

    A1-A2 (Grundkenntnisse)

  • Hindi

  • kannada

  • Marathi

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