IT Compliance Advisor

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