Mahesha Anandamurthy

Angestellt, CSV Professional (Computerized Systems Validation), Sartorius Stedim Ind Pvt Ltd

Bengaluru, Indien

Fähigkeiten und Kenntnisse

Computer System Validation (CSV)
System validation according to GAMP
FDA Regulation
Validation
IT-Compliance
GMP Compliance
Regulatory Compliance
Life sciences
Software Development Lifecycle
Software Quality Assurance
QM-Systeme
ISO 13485
EU Annex 11
SAP ERP
SAP Cloud Platform
SAP
Audit
ISO 27001
Quality Management
IT Governance
GxP
ISO
GMP
Biotechnology
English Language
Risk Analysis
GAMP 5
Annex 11
21 CFRPart 11
Computer Software Assurance (CSA)
Computerized System Validation (CSV)
FDA 21 CFR Part 820
Agile and Waterfall methodologies
SAP ECC
SAP S/4HANA
Cloud Applications
ISO 13845

Werdegang

Berufserfahrung von Mahesha Anandamurthy

  • Bis heute 2 Jahre und 9 Monate, seit Aug. 2021

    CSV Professional (Computerized Systems Validation)

    Sartorius Stedim Ind Pvt Ltd

    • As a Validation Engineer am responsible for supporting the Computerized System Validation capability within the assurance function in the Quality and Compliance Team. • Ensuring the GxP-compliant validation of software, applications, and IT infrastructure within the scope of projects and digital transformation. • Applying a risk-based approach from ISPE GAMP 5 and CSA throughout the System Lifecycle.

  • 1 Jahr und 5 Monate, März 2020 - Juli 2021

    Senior Validation Engineer

    Capgemini Technology Services India Limited

21 Mio. XING Mitglieder, von A bis Z