Job Summary

We are seeking a hands-on CSV Software QA Engineer to support software testing, computer system validation, and quality assurance activities for our life sciences automation platforms. The candidate will work closely with development teams, regulatory SMEs, and validation consultants to ensure software quality, regulatory compliance, and audit readiness.

Responsibilities

Computer System Validation (CSV)

- Prepare and execute CSV documentation, including validation plans, URS, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
- Support risk-based validation approaches aligned with GAMP 5 and applicable GxP requirements.
- Maintain validation evidence, deviations, and change control documentation.
- Support validation activities for new releases, enhancements, and customer implementations.

Software Quality Assurance Testing

- Design and execute functional, integration, system, and regression test cases.
- Test end-to-end business workflows, document management, approvals, electronic signatures, audit trails, and access controls.
- Perform API testing and database validation where required.
- Identify, document, track, and retest defects.
- Support automated regression testing using Playwright, Selenium, or similar tools.

Regulatory Platform Testing

- Test pharmaceutical regulatory workflows across RIM, document management, assisted authoring, eCTD submissions, and regulatory change management.
- Verify AI-assisted outputs against source documents and defined acceptance criteria.




- Collaborate with regulatory SMEs on business scenarios and user acceptance testing.

Required Qualifications

- 3 7 years of experience in software QA, testing, and/or computer system validation.
- Practical experience with CSV documentation and execution in pharmaceutical, biotechnology, or life sciences environments.
- Understanding of GxP, GAMP 5, FDA 21 CFR Part 11, and data integrity principles.
- Robust functional and regression testing experience.
- Experience with test management and defect tracking tools such as Jira or Azure DevOps.
- Ability to create clear test cases, validation evidence, and technical documentation.
- Good communication and analytical skills.

Preferred Qualifications

- Experience with Veeva Vault, RIM, EDMS, eQMS, LIMS, or similar regulated enterprise applications.
- Experience with Playwright, Selenium, Postman, SQL, or Python.
- Familiarity with Agile software development and CI/CD.
- Knowledge of pharmaceutical regulatory submissions and document workflows.
- Exposure to AI-enabled enterprise applications.

What We Are Looking For

A detail-oriented, hands-on engineer who combines software testing capabilities with CSV knowledge and can contribute to both product quality and regulatory compliance.

Job Features

Job Category

Engineering Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 CSV & Software QA Engineer (Hyderabad)
🏢 Mushroom Solutions
📍 Hyderabad