Computer System Validation(CSV)

Job Description

Position: Computer System Validation Engineer Experience: 5+ years Location: Anywhere in India Mandates: Computer System Validation (CSV) Requires Competences: Domain specific competencies preferably Supply chain domain. Knowledge on Statutory requirements for the role like FDA, Sox, etc. Strong Interpersonal skills Strong knowledge in FDA E2E Validation, GAMP 5, ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485 and EU Annex 11 Expertise in validation of enterprise-wide Quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines. Experience and Background: Domain or related IT experience of 5-8 Years Worked in software development implementation projects as a validation Engineer in multiple global software development implementation projects. Certified in ITIL / ISTQB (foundation) or good understanding in Change management or flows Experience in IT Software Validation methodology in regulated medical device, pharmaceutical and healthcare industry CSA experience is an added advantage. Education: Bachelor s degree or Master s degree (In Science, Pharmaceutical, Biotechnology or lifescience) About the Client: The client is an Indian multinational corporation that provides information technology, consultant and business process services. It is one of the leading Big Tech companies.