Talent.com
This job offer is not available in your country.
IT Compliance Advisor

IT Compliance Advisor

IQVIABengaluru, Karnataka, India
30+ days ago
Job description

Project Role : IT Compliance Advisor

Experience : 4-7 years

Job Location : Bengaluru / Pune / Kochi

Work Mode : Hybrid

Must Have Skills : Compliance, Validation and Testing, GXP, System life cycle

Domain Knowledge : Healthcare, CRO, Life Science

Job Description Summary :

Compliance and Validation

  • Hands-on experience in compliance and validation roles
  • Strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5
  • System validation aligned with regulatory standards
  • Review of validation artifacts and identification of traceability or documentation gaps

System Life Cycle and Methodologies

  • Well-versed with System Life Cycle
  • Hands-on experience with Validation approach, Agile methodology, AIML concepts

    • Testing / Validation Experience

  • Review and preparation of : Test Plans, Validation Plans, Risk Assessments
  • Requirement Traceability Matrix (RTM), Summary Reports
  • Understanding of the defect lifecycle and validation deliverables

    • Tools and Technologies

  • Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systems

    • Quality & Domain Expertise

  • Knowledge of Quality Management Systems (QMS)
  • Experience in Healthcare, CRO, or Life Sciences environments

    • Good to Have Skills :

  • Experience with SaaS validation, automation, and vendor audits
  • Participation in internal / regulatory audits
  • Strong documentation skills (SOPs, templates, work instructions)
  • Familiarity with risk-based validation and data management

    • Educational Qualification : Any Graduate

    Create a job alert for this search

    Compliance Advisor • Bengaluru, Karnataka, India