Senior It Auditor, Clinical Research (Bengaluru)

Senior It Auditor, Clinical Research (Bengaluru)

01 Aug
|
Iqvia
|
Bengaluru

01 Aug

Iqvia

Bengaluru

Job Overview Plan and conduct independent technology audits to assess compliance with regulations guidelines and operating procedures Prepare and distribute reports of findings to supervisor operations staff management and customers Provide consultation in interpretation of regulations guidelines policies and procedures Support management in promotion and assessment of compliance to regulations guidelines and corporate policies Essential Functions Plan schedule conduct report and close audit activities across countries to assess compliance with regulations customer requirements SOPs and project guidelines Audit Planning Strategy Perform risk assessments on technology vendors determine audit type scope and cadence Audit Execution Lead qualification for-cause and surveillance audits of vendors delivering eClinical solutions medical information systems data hosting analytics AI ML tools DCT components and GxP-relevant cloud services Evaluate audit findings and prepare reports Provide interpretation on regulations guidelines compliance status policies and procedures Consult customers and monitors on audit observations and CAPA plans Manage Quality Issues as required Deliver training and guidance on compliance procedures Review and approve investigations RCA CAPA and EC plans track quality events to closure Evaluate policies for compliance and recommend process improvements Host audits inspections and support regulatory inspection readiness Maintain eQMS updates and support audit lifecycle activities Lead support QA improvement initiatives and train new QA staff Qualifications Bachelor s degree in Life Sciences Computer Science Information Systems 10 years of experience in pharmaceutical technical or related GxP QA CSV IT audit roles Solid knowledge of R D processes regulatory environments and SaaS eClinical vendor auditing Ability to work independently and lead onsite remote audits internationally Strong interpersonal problem solving risk analysis negotiation training and communication skills Location Bengaluru Hybrid Global travel up to 20-40 depending on study vendor portfolio IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide Learn more at

📌 Senior It Auditor, Clinical Research (Bengaluru)
🏢 Iqvia
📍 Bengaluru

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