You will be part of a highly motivated, collaborative, and diverse Computer Software Assurance / Validation Team. Job description: Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field Minimum 3+ years experience in IT & Software Validation (CSV/CSA, GAMP) Good knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) Good understanding of system and data risk assessment General understanding of Agile Methodology(Framework (i.e. SAFe, Scrum), previous experience would be an advantage. Ability to work collaboratively in cross-functional and agile teams to achieve milestones and goals Effective communicator with excellent verbal and written communication skills - English language mandatory Assertiveness and ability to work with diverse personalities/cultures Lets find out what a usual day of work might look like. You will: Determine validation approaches, and identifies deliverables needed or impacted by a project / enhancement / change for GxP computerized systems Be responsible for the review of system documentation according to the Roche CSV SOPs and regulatory guidance Develop validation plans/reports, reviews test plans/reports (and other deliverables), and assess, authorize, and notify that the system is ready to go live Verify testing plans, activities, deliverables, and records, provide consultancy on test-related deviations and corrective actions according to approved procedures Support in deviation investigations to identify root causes and define corrective and/or preventative actions Support system audit/inspection preparation and execution as CSV subject matter expert Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready Support system periodic reviews according to company procedure We offer: dedicated training budgets and many opportunities for personal and professional self-development (training, conferences, diversified career paths, etc.) a workplace that supports innovation and new ideas attractive benefits & business travel opportunities work in a great team with international colleagues on exciting topics to shape the IT behind the healthcare of tomorrow
The Position: Software Test Engineer Heres what we’re looking for: We are looking for Software Test Engineer to join one of our Agile development team in Pune. The ideal candidate will be responsible for ensuring the quality and reliability of our software products by performing thorough testing activities throughout the development lifecycle. You will work closely with developers, product owners, and other stakeholders to deliver high-quality software in a fast-paced, iterative environment. We are committed to quality through a meticulous process that includes detailed requirements gathering, in-depth design analysis, and comprehensive testing. Our approach combines functional, automation, and regression testing to ensure thorough coverage, supported by focused quality initiatives and CI/CD principles. Works independently within guidelines and policies, receives minimal guidance. If this resonates with you, we would love to hear from you! Essentials skills for your mission: Bachelor’s degree in computer science, Information Technology, or a related field. At least 3 years of work experience in a software testing position and good knowledge of processes and methods in verification & validation of systems. Hands-on software requirement and test design analysis, prepare functional and regression test case, automated test development and execution, Experience working with automation frameworks, preferably in Java, Playwright, TestNG and Rest Assured. Drive towards testing excellence, measuring against key performance indicators that you help to establish, maintain, and work to improve the speed, predictability, quality, and flexibility of software testing. Experience integrating automated tests into CI/CD pipelines particularly utilizing GitHub. Strong debugging and troubleshooting skills to identify root causes of test failures in backend systems. Practical experience in writing and executing SQL queries for backend data verification, including joins, filters, and aggregations. Use problem-solving and analytical skills to identify, isolate, and reproduce software defects. Proficiency with tools like JIRA/Xray/Confluence. Expertise in writing use case and test case in the BDD framework. Strong comprehension, analytical, and problem-solving skills. Great written and verbal communication in English Bonus skills: Knowledge in special verification methods/disciplines e.g. performance testing. Knowledge of customer workflows in the area of Laboratory Automation. Experience in Healthcare and Life Science. Experience in the development of medical software. Familiarity with hosting services like AWS. Experience and certificate with SAFe. Locations You will be based in Pune, India
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