Role Overview:

We are looking for a detail-oriented IT QA Engineer to ensure the quality, reliability, and performance of software releases across our digital platforms within a regulated pharmaceutical environment. This role will work closely with developers, product managers, and business stakeholders to validate that all releases meet defined requirements, GxP compliance standards, and are production-ready.

Key Responsibilities:

- Review business and functional requirements to create comprehensive test strategies and test cases
- Perform manual and/or automated testing for software releases
- Validate end-to-end workflows across systems before production deployment
- Identify, document, and track bugs/issues using tools like JIRA or similar
- Conduct regression, integration, and UAT support testing
- Ensure data integrity, system performance, and security compliance during releases
- Ensure compliance with GxP regulations and GAMP 5 guidelines
- Execute validation activities including IQ, OQ, and PQ as applicable
- Maintain validation documentation including test cases, traceability matrices, and validation reports
- Collaborate with development teams to resolve defects and improve quality
- Participate in release planning, sprint reviews, and QA sign-offs
- Continuously improve QA processes, tools, and frameworks

Required Skills & Qualifications:

- Bachelor’s degree in computer science, IT, or related field




- 2–4 years of experience in Software QA / Testing
- Robust understanding of SDLC and STLC processes
- Knowledge of GxP compliance and GAMP 5 framework
- Experience with test case design, execution, and defect tracking
- Hands-on experience with tools like JIRA, TestRail, or similar
- Familiarity with API testing (Postman or similar)
- Basic understanding of databases (SQL) for data validation
- Strong analytical and problem-solving skills
- Excellent communication and documentation abilities

Preferred Skills:

- Experience with test automation tools (Selenium, Cypress, etc.)
- Exposure to CI/CD pipelines (Azure DevOps, Jenkins, GitHub Actions)
- Knowledge of Agile/Scrum methodologies
- Experience in pharmaceutical, biotech, or other regulated environments

Key Competencies:

- Attention to detail
- Strong documentation and compliance mindset
- Ownership of release quality
- Ability to work in cross-functional teams
- Risk identification and mitigation thinking

Success Metrics:

- Reduction in production defects
- Timely QA and validation sign-offs
- Compliance with regulatory and audit requirements
- Improved release stability and reliability

Why Join Us:

- Opportunity to work in an AI-driven, fast-growing biotech organization
- Exposure to cutting-edge digital transformation initiatives
- Collaborative and innovation-focused work culture

📌 IT Quality Assurance Engineer Software Releases (Navi Mumbai)
🏢 BioSimilar Sciences India
📍 Navi Mumbai