IT Compliance Advisor

1 week ago

Bengaluru, India IQVIA Full time

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

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