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Quantiphi
Quantiphi
1001 – 5000 Zaposleni
Sponzor vizuma H1BLogistikaSvetovanjeZdravstveno varstvo
Quantiphi je podjetje za digitalno inženirstvo, ki se osredotoča predvsem na umetno inteligenco ter organizacijam pomaga uporabljati umetno inteligenco, podatke in tehnologije v oblaku pri reševanju zapletenih poslovnih izzivov. Podjetje, ustanovljeno leta 2013, združuje svetovalno in inženirsko strokovno znanje za razvoj razširljivih aplikacij umetne inteligence, vzpostavljanje zmogljivosti podatkovne analitike, posodabljanje infrastrukture v oblaku in zagotavljanje rešitev po meri. Njegovo delo podpira organizacije v sektorjih, kot so zdravstvo, finance, izobraževanje, maloprodaja in logistika, med tehnološkimi partnerji pa so AWS, Google Cloud in NVIDIA. Ekipe podjetja se osredotočajo na pretvarjanje napredne tehnologije v praktične rešitve za preobrazbo podjetij.
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Delovna mesta v podjetju

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.

INIndijaNa lokacijiPolni delovni časSrednja ravenZahtevani Jezik: angleščinaVodja
AWSAzureGoogle Cloud PlatformOblakTerraformVaultVMware

Opis

  • 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.

Zahteve

  • 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.

Ugodnosti

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

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