Job Title

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