Description :

Role Summary :

The QA Analyst will be responsible for validating enterprise applications with a strong focus on regulatory compliance, eTMF systems, and GxP environments.

The role demands strong manual and functional testing experience, documentation expertise, and an understanding of 21 CFR Part 11 and ICH-GCP guidelines.

Key Responsibilities :

- Develop, execute, and document test cases, test scenarios, and test scripts.

- Perform functional, regression, integration, and system-level testing.

- Work on eTMF systems, validating workflows, access control, and audit trails.

- Ensure software adherence to 21 CFR Part 11, GxP, and ICH-GCP compliance.

- Conduct defect investigation, root-cause analysis, and track issues in JIRA.

- Perform validation documentation such as IQ, OQ, PQ, and validation summary reports.

- Collaborate with product owners and development teams to refine requirements.

- Ensure traceability of requirements, risks, and test coverage.

Required Skills :

- Strong hands-on experience in manual testing

- Good understanding of GxP systems, eTMF workflows, and compliance frameworks

- Experience with JIRA, TestRail, or similar test management tools

- Good SQL skill for data validation

- Understanding of software development lifecycle (SDLC & STLC)

Preferred Skills :

- Experience with automation testing (Selenium, Cypress, or similar)

- Knowledge of pharmaceutical/clinical trial domain

- Familiarity with cloud-based eTMF platforms

Qualifications :

- Bachelors degree in Computer Science, Engineering, Life Sciences, or related field

- Certifications in QA, ISTQB, or GxP Compliance preferred