Overview
Skills
Job Details
Job Title: Computer Systems Quality Assurance (CSV / IT QA)
Location: Indianapolis, IN (Onsite preferred; Remote in US possible)
Work Hours: EST Time Zone
pranayatburgeonitsdotcom
Role Description
We are looking for an experienced Computer Systems Quality Assurance (CSV) professional to support the validation and quality compliance of ERP and related systems used in manufacturing. The role ensures systems are implemented and maintained according to GxP and corporate CSV standards and supports inspection readiness activities.
Key Responsibilities
Ensure systems are validated and remain in a compliant state.
Support audits, internal assessments, and inspection readiness.
Review and approve validation deliverables as per CSV guidelines.
Collaborate with Business, Quality, and IT teams.
Provide guidance and training on CSV processes and best practices.
Manage and track quality actions/CAPA items.
Required Experience
7 12 years of experience in IT CSV / IT Quality / eCompliance.
Pharma or Life Sciences industry experience is mandatory.
Hands-on experience with:
Clinical Trial / CTMS or Statistical/Reporting Systems validation
Veeva Quality Docs
ServiceNow
JIRA
HP ALM