CSV Lead

CGxPServe

Posted on : 18-09-2025

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1 Vacancy

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Job Location

Indianapolis, IN - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 18-09-2025

Job Description

Job Description:

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 Client-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.

Employment Type

Full-time

Company Industry

Key Skills

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About Company

CGxPServe

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CSV Lead

CGxPServe

Job Description

Employment Type

Company Industry

Key Skills

About Company

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