IT Compliance Advisor

4 weeks 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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