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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