Summary Compliance and Validation Hands-on experience in the role of Compliance and Validation Well-versed with GxP GDPR FDA Part 11 and standard regulations Knowledge of 21 CFR part 11 GxP regulations GAMP 5 guidelines System validation in alignment with GxP and regulatory requirements Good knowledge of assessing Traceability gaps improper verification of requirements improper attached evidences and raised observations for each deviation Hands-on experience in reviewing validation artifacts and quality reviews System Life Cycle and Methodologies Well-versed with System Life Cycle Hands-on experience with Validation approach Agile methodology AIML concepts Testing Validation Experience Exposure in reviewing Test Plans Test Summary Reports Development of System Validation Lifecycle documents Risk Analysis Validation Plan Validation Summary Report Preparation and Review of validation deliverables Validation plan Functional Risk Assessment Requirement Traceability Matrix Qualification Summary Report Good knowledge about the defect life cycle Tools and Technologies - Hands-on experience with tools like HP ALM Jira TrackWise Veeva QMS systems Quality Management - Knowledge of Quality Management System QMS Domain Knowledge - Healthcare CRO Life Sciences domain knowledge Good to Have Skills SaaS Validation and Process -Familiarity with SaaS validation and process System Validation Analysis and development of System Validation Lifecycle documents Risk Analysis of system and requirements Compliance and Audits - IT and CSV compliance and audit of third-party vendors Participation in internal audits and or regulatory audits to represent CSV and IT compliance Vendor Management - Vendor evaluation and qualification Testing Validation Process - Knowledge about Testing Validation process automation Software Development Life Cycle SDLC - Valuable knowledge about the SDLC process Data Management and Risk-Based Approach - Good knowledge on data management risk-based approach Documentation - Experience in authoring and improving SOPs work instructions and templates 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 https jobs iqvia com

📌 It Compliance Advisor 2 (Karnataka)
🏢 Iqvia
📍 Karnataka