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About the role
At PwC, you will be part of a vibrant community of solvers that leads with trust and creates distinctive outcomes for our clients and communities. This purpose-led and values-driven work, powered by technology in an environment that drives innovation, will enable you to make a tangible impact in the real world. We reward your contributions, support your wellbeing, and offer inclusive benefits, flexibility programmes and mentorship that will help you thrive in work and life. Together, we grow, learn, care, collaborate, and create a future of infinite experiences for each other. Learn more about us . Responsibilities Having 4 - 8 years of work experience in Computer System Validation (CSV), Software Testing and IT Compliance. Exposure in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC). Knowledge of SDLC methodology like Waterfall and Agile model and V model of CSV. Experience in manual testing like Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing and defect tracking and reporting. (Preferred exposure to CSV tools such as Valgenesis ) Knowledge of GAMP5 Guideline, GxP , US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles. Knowledge of Change Control, Deviation Management, CAPA and Periodic Review. Experience in authoring Computer System Validation deliverables like GxP Assessment, Validation Plan (VP), User Requirement Specifications( URS), Functional Requirement Specifications( FRS), Functional Risk Assessment (FRA) using FMEA, Design Specifications (DS), IQ/OQ/PQ protocols, Validation Summary Report (VSR) Mandatory Skill sets Data Privacy Preferred Skill sets Data Protection Years of Experience required 7 Education Qualification: B.Tech Education Degrees/Field of Study required: Bachelor of Technology, Bachelor of Engineering Degrees/Field of Study preferred: Required Skills Creating Shared Value (CSV) Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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