Computer Systems Quality Assurance

Job Title: Computer Systems Quality Assurance Location: Indianapolis, IN, 46278 (Hybrid – 3-4 times onsite per month)

Experience: 7–12 years Duration: 12 Months Contract Visa: H4-EAD Only Industry: Pharmaceutical

Role Overview

We are seeking an experienced Computer Systems Quality Assurance (CSQA) professional to support the expansion of ERP systems and associated applications across new and existing manufacturing sites. This role is responsible for providing quality oversight to ensure systems are developed, validated, and maintained in alignment with corporate Computer System Validation (CSV) standards and regulatory compliance.

Key Responsibilities

Provide quality assurance oversight for ERP systems and related applications.

Ensure compliance with corporate CSV standards, GxP regulations, and industry best practices.

Review, approve, and support validation documentation (plans, test scripts, reports).

Collaborate with IT, QA, and business stakeholders to ensure system readiness and compliance.

Support audits, inspections, and internal assessments related to IT systems.

Track and manage issues using systems like ServiceNow, JIRA, and HP ALM.

Mandatory Skills

Strong expertise in IT CSV (Computer System Validation) .

Hands-on experience in IT Quality Assurance / QA eCompliance Management .

Proficiency with tools such as Veeva Quality Docs, ServiceNow, JIRA, and HP ALM .

Pharmaceutical industry experience is mandatory.