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Stark Pharma Solutions Inc
CSV Quality Assurance Engineer

CSV Quality Assurance Engineer

Hybrid

Indiana, United states

Senior

Freelance

19-09-2025

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Skills

Jira ServiceNow Test Quality Assurance ERP Systems

Job Specifications

Job Title: CSV Quality Assurance Engineer

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 CSV Quality Assurance Engineer 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.

About the Company

Established in 2014, Stark Pharma is a trusted consulting service partner for pharmaceutical, medical device, biotech, and IT clients. With direct operations in USA, Canada, and India, we bring a wealth of expertise and tailored solutions to help our clients achieve their strategic goals. Our Services: 1. Pharma, Medical Device & Biotech Consulting: We specialize in delivering expert guidance across: * Design & R&D * Formulation Development * Analytical R&D * Regulatory Affairs * Validation & Quality Assurance * Manufacturin... Know more