CSV Engineer For Indianapolis, IN at Indianapolis, Indiana, USA |
Email: [email protected] |
From: Manish Kumar, Scalable Systems [email protected] Reply to: [email protected] Position:CSV Engineer : Location: Indianapolis Demonstratable Experience in Computer System Validation (CSV) Experience in software development processes (SDLC) and software testing life cycle (STLC) Experience in drafting, reviewing, revising, and maintaining validation documents (CSV), including Compliance Analysis, Compliance Plan, Change Control Document, User & Functional Requirement documents, Risk Assessments (Risk Register), Test (ST/UAT/Regression) Protocol, Test Defect Report, Test Summary Report, Compliance Summary Report, Traceability Matrix, Hypercare Plan, Operation Run Book and other validation & technical documentation. Experience in drafting Standard Operating Procedures (SOP) and Work Instructions (WI) Strong knowledge of JIRA, HP-ALM, qTest tools Knowledge of validation & testing in projects implemented using agile methodology Knowledge about Agile techniques like: User Stories, Continuous Testing, tasks, etc. Ability to take and understand the commitment to deliver the product on time. GxP experience is required Experience of validation support for 21 CFR Part 11 implementation in Pharma industries. Experience working within a FDA/Other regulated pharma industry. Best Regards Manish Kumar Phone - +17327883626 Email ID: [email protected] Scalable Systems | Inspiring Innovation Big Data | Analytics | Integration | Intelligence www.scalable-systems.com Keywords: hewlett packard Idaho Wisconsin CSV Engineer For Indianapolis, IN [email protected] |
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Wed Dec 11 03:10:00 UTC 2024 |