CSV QA Lead IRC270491

Description
At GlobalLogic, we believe in pushing the boundaries of what's possible. As a CSV QA Automation expert, you'll have the opportunity to work on brand new projects in a collaborative and ambitious environment. You'll be part of a team that is dedicated to delivering flawless software solutions and ensuring the highest standards of quality and compliance.

Requirements

• Experience: 7+ years in life sciences/healthcare domain with strong validation knowledge
• Responsibilities:

○ Define CSV strategy for cloud-based and serverless systems

○ Prepare and maintain IQ, OQ, PQ documents

○ Manage traceability matrix, validation plans, and summary reports

○ Interface with customer CSV leads and regulatory teams

○ Participate in audits and ensure documentation compliance

○ Define and implement overall QA strategy and test planning for the project

○ Oversee test case design, test data management, test execution, and defect reporting

○ Lead the QA team across functional, regression, integration, and system testing phases

○ Coordinate with the development team for early involvement in feature analysis and defect resolution

○ Drive automation strategy and ensure appropriate test coverage through automation tools

○ Track and report QA metrics, including test progress, defect rates, and coverage

○ Support UAT execution and customer communication regarding testing readiness

Job responsibilities

○ GAMP 5, 21 CFR Part 11, Annex 11

○ Validation documentation tools

○ Experience in regulated SaaS/cloud deployments

○ Strong knowledge of testing methodologies, tools, and processes (e.g., Agile, Waterfall)

○ Hands-on experience with automation tools like Selenium, Cypress, JUnit, TestNG

○ Familiarity with bug tracking and test management tools (e.g., JIRA, Zephyr, TestRail)

○ Understanding of performance, security, and compatibility testing

○ Excellent communication and team management skills

○ Exposure to healthcare/regulated domain

What we offer

Culture of caring.
At GlobalLogic, we prioritize a culture of caring. Across every region and department, at every level, we consistently put people first. From day one, you'll experience an inclusive culture of acceptance and belonging, where you'll have the chance to build meaningful connections with collaborative teammates, supportive managers, and compassionate leaders.

Learning and development.
We are committed to your continuous learning and development. You'll learn and grow daily in an environment with many opportunities to try new things, sharpen your skills, and advance your career at GlobalLogic. With our Career Navigator tool as just one example, GlobalLogic offers a rich array of programs, training curricula, and hands-on opportunities to grow personally and professionally.

Interesting & meaningful work.
GlobalLogic is known for engineering impact for and with clients around the world. As part of our team, you'll have the chance to work on projects that matter. Each is a unique opportunity to engage your curiosity and creative problem-solving skills as you help clients reimagine what's possible and bring new solutions to market. In the process, you'll have the privilege of working on some of the most cutting-edge and impactful solutions shaping the world today.

Balance and flexibility.
We believe in the importance of balance and flexibility. With many functional career areas, roles, and work arrangements, you can explore ways of achieving the perfect balance between your work and life. Your life extends beyond the office, and we always do our best to help you integrate and balance the best of work and life, having fun along the way

High-trust organization.
We are a high-trust organization where integrity is key. By joining GlobalLogic, you're placing your trust in a safe, reliable, and ethical global company. Integrity and trust are a cornerstone of our value proposition to our employees and clients. You will find truthfulness, candor, and integrity in everything we do.

About GlobalLogic
GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world's largest and most forward-thinking companies. Since 2000, we've been at the forefront of the digital revolution – helping create some of the most innovative and widely used digital products and experiences. Today we continue to collaborate with clients in transforming businesses and redefining industries through intelligent products, platforms, and services.