IT Compliance Advisor

2 weeks ago


bangalore, India IQVIA Full time

Project Role: IT Compliance AdvisorExperience: 4-7 yearsJob Location: Bengaluru/Pune/KochiWork Mode: HybridMust Have Skills: Compliance, Validation and Testing, GXP, System life cycleDomain Knowledge: Healthcare, CRO, Life ScienceJob Description Summary:Compliance and ValidationHands-on experience in compliance and validation rolesStrong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5System validation aligned with regulatory standardsReview of validation artifacts and identification of traceability or documentation gapsSystem Life Cycle and MethodologiesWell-versed with System Life CycleHands-on experience with Validation approach, Agile methodology, AIML conceptsTesting/Validation ExperienceReview and preparation of: Test Plans, Validation Plans, Risk AssessmentsRequirement Traceability Matrix (RTM), Summary ReportsUnderstanding of the defect lifecycle and validation deliverablesTools and Technologies Hands-on experience with tools like HP ALM, Jira, TrackWise, Veeva, QMS systemsQuality & Domain ExpertiseKnowledge of Quality Management Systems (QMS)Experience in Healthcare, CRO, or Life Sciences environmentsGood to Have Skills :Experience with SaaS validation, automation, and vendor auditsParticipation in internal/regulatory auditsStrong documentation skills (SOPs, templates, work instructions)Familiarity with risk-based validation and data managementEducational Qualification: Any Graduate


  • It compliance advisor

    4 weeks ago


    Bangalore, India IQVIA Full time

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