Computer System Validation- CSV

Computer System Validation- CSV

Location : Bangalore

Exp : 5+Yrs

Key Responsibilities :

Perform validation activities for software tools such as Atlassian suite (JIRA, Confluence, Crowd), ELM Suite (RQM, DNG), Windchill, JFrog Artifactory, GitHub.

Create and maintain validation documentation including test protocols, plans, reports, Change Requests, Validation Plans, Risk documentation, etc.

Draft and update procedural documentation in compliance with GxP standards and obtain necessary approvals.

Execute validation scripts and manage formal testing processes for GxP systems.

Handle user access management and admin requests for tools like JIRA, RQM, and GitHub.

Manage tool-related service admin requests via ServiceNow.

Support change control, lifecycle management, and impact assessments for CSV tools.

Collaborate with cross-functional teams (e.g., SQM) to ensure compliance and audit readiness.

Ensure compliance with 21 CFR Part 11 and other GxP regulatory standards.

Apply data integrity principles to all validation and documentation activities.

Develop and maintain validation documentation such as URS, FRS, IQ, OQ, and PQ.

Implement risk-based validation approaches to optimize compliance efforts.

Manage change control, deviation handling, and CAPA processes effectively.

Validate software tools used in regulated environments to ensure compliance and functionality.

Provide support during audits and inspections, ensuring readiness and documentation accuracy.

Knowledge on tools like RQM, DNG, JIRA, Confluence, JFrog Artifactory, and GitHub at both user and admin levels is a added benefit.

Skills :

Strong understanding of CSV (Computer System Validation) principles and lifecycle

Experience with GxP systems and regulatory compliance (e.g., 21 CFR Part 11, GxP Standards)

Basic understanding of data integrity principles

Hands-on experience in validation documentation : URS, FRS, IQ, OQ, PQ

Familiarity with risk-based validation approaches

Knowledge of change control, deviation management, and CAPA processes

Experience in validating software tools used in regulated environments

Ability to work with cross functional teams(SQM) to ensure compliance

Good to have

Familiarity with tools like RQM, DNG, JIRA, Confluence, JFrog Artifactory, and GitHub (user / admin level)

Exposure to audit processes