
IT Specialist for Computer System Validation
8 hours ago
Are you a skilled IT professional looking for a challenging role in Computer System Validation (CSV)? We are seeking an experienced consultant to join our team and assist with various CSV projects.
- 4-8 years of experience in CSV, Software Testing and IT Compliance is essential.
- Exposure to Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC) is required.
The ideal candidate will have knowledge of SDLC methodology like Waterfall and Agile model and V model of CSV, as well as GAMP5 Guideline, GxP, US FDA 21 CFR Part 11, EU Annex 11 and ALCOA+ principles. They should also have experience in manual testing, including Positive & Negative Testing, Regression Testing, Smoke, Sanity Testing and defect tracking and reporting.
Apart from technical skills, the candidate should be able to work effectively as part of a team, communicate complex ideas clearly and prioritize tasks efficiently.
Responsibilities:- Authoring Computer System Validation deliverables, including 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, and Validation Summary Report (VSR).
We offer a dynamic work environment with opportunities for growth and development. If you are passionate about CSV and want to take your career to the next level, we encourage you to apply.
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