Csv Validation Engineer

Role & responsibilities

Conduct CSV activities such as risk assessment, gap analysis, and validation planning.

Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11.

Ensure compliance with EU Annexure 11 requirements for software validation of ERP system.

Develop test scripts and execute tests using V-model approach.

Preparation, Execution, Compilation and approval of below documents (Not limited to)

1) User requirement specifications

2) Validation Plan

3) GxP Assessment

4) System Design Specification

5) Risk Assessment

6) Network (Infra) Qualification

7) Installation Qualification protocol

8) Operational Qualification

9) Performance Qualification

10) Traceability matrix

11) Validation summary report