Job Description:

Minimum qualifications :

• The minimum education required for this position is bachelor's or equivalent degree in computer science, technology or engineering or other related technical field with 0-3 years of experience
• 2+ years of Software Development life Cycle (SDLC), Watetiall, V-shape and Agile models in relation to development and testing.
• Experience required in preparing and reviewing Test Plans, Validation protocols (Installation Qualification • IQ, Operational Qualification • OQ and Performance Qualification • PQ), Test Summary Report and Validation Summary Report (VSR).
• 2+ Experiance in 21 CFR Part 11 GxP requirements including electronic records, electronic signatures, system validation strategies and documentation, conducting High level Risk Assessment (HLRA) and documenting as per GAMP 5 guidelines.

Preferred qualifications :

• Strong Knowledge required in Deviation resolution including Root Cause Analysis, CAPA closeouts and Deviation reports, HTML, CSS, Drupal CMS, Axway Track & Trace, SAP AJTP