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Quantiphi
Quantiphi
1.001 – 5.000 Angajați
Sponsor pentru viza H1BAsistență medicalăConsultanțăLogistică
Quantiphi este o companie de inginerie digitală axată pe inteligența artificială, care ajută organizațiile să aplice inteligența artificială, datele și tehnologiile cloud pentru a aborda provocări complexe de afaceri. Fondată în 2013, compania combină expertiza în consultanță și inginerie pentru a construi aplicații de inteligență artificială scalabile, a dezvolta capacități de analiză a datelor, a moderniza infrastructura cloud și a furniza implementări personalizate. Activitatea sa sprijină organizații din sectoare precum sănătatea, finanțele, educația, retailul și logistica, prin parteneriate tehnologice care includ AWS, Google Cloud și NVIDIA. Echipele Quantiphi se concentrează pe transformarea tehnologiilor avansate în soluții practice pentru transformarea organizațiilor.
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Associate Engagement Manager, GxP Validation — Mumbai On-site

Lead GxP validation and cloud infrastructure qualification for Quantiphi. Support regulated life sciences systems from an on-site role in Mumbai, Bengaluru, or Trivandrum.

INIndiaLa sediuNormă întreagăNivel mediuLimbă Obligatorie: englezăManager
AWSAzureCloudGoogle Cloud PlatformTerraformVaultVMware

Descriere

  • Lead GxP validation across infrastructure components.
  • Direct IQ, OQ, and PQ for cloud platforms, virtualized environments, networks, and storage and backup systems.
  • Create and review validation plans, URS, FS/DS/CS, risk assessments, traceability matrices, and summary reports using GAMP 5 risk-based methods.
  • Execute protocols and capture evidence such as logs, screenshots, and system outputs.
  • Set validation strategies for GxP-compliant IaaS, PaaS, and SaaS environments.
  • Qualify cloud services, including IAM, logging, encryption, and backup and disaster recovery.
  • Maintain alignment with FDA 21 CFR Part 11 and EMA EU Annex 11.
  • Apply ALCOA+ principles, audit trail requirements, and controls for electronic records and signatures.
  • Use GAMP 5 risk-based validation, including system categorization and GxP impact assessments.
  • Promote adoption of Computer Software Assurance.
  • Support the validation lifecycle through periodic reviews, requalification, and change-control impact assessments.
  • Work with IT and DevOps teams on infrastructure changes, patch management, and configuration drift validation.

Cerințe

  • The stated experience range is 5–12 years.
  • At least 5 years of GxP CSV or validation experience.
  • At least 3 years of hands-on infrastructure qualification experience.
  • Hands-on cloud qualification experience with AWS, Azure, or GCP.
  • Experience with VMware or Hyper-V virtualization.
  • Experience validating network components.
  • Experience in a regulated field such as life sciences, healthcare, or medical devices.
  • Proficiency in IAM, RBAC, encryption, and SIEM or logging tools.
  • Familiarity with validation tools such as HP ALM, Azure DevOps, and Jira.
  • Experience creating SOPs, validation plans, and RTMs.
  • Preferred: experience with LIMS, QMS, MES, or Veeva Vault.
  • Preferred: experience with Terraform or CloudFormation.
  • Preferred: knowledge of DevOps or CI/CD validation practices.
  • Preferred: knowledge of AI/ML system validation.
  • Preferred: experience with automated testing tools.
  • Ability to design validation strategies and troubleshoot qualification issues.

Beneficii

  • A culture centered on transparency, diversity, integrity, learning, and growth.
  • An environment that encourages innovation and professional and personal development.

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