Testing - CSV\GxP Regulation

4 days ago

Hyderabad, Telangana, India BIG4 Full time

IT QA Analyst – CSV\ GxP Systems Testing and Support

Role Summary

The IT QA Analyst – GxP Systems Testing is responsible for supporting validation and testing activities for GxP computer systems. This role ensures that all testing and documentation meet internal quality standards and regulatory expectations. The incumbent will work under the guidance of senior QA and CSV personnel, contributing to the execution of test scripts, documentation reviews, and day-to-day QA support for system implementations, upgrades, and maintenance.

Key Responsibilities

· Review and approve validation testing (IQ/OQ/PQ) and related activities under guidance from senior QA staff.

· Review and approve test scripts, requirements traceability matrices, and validation deliverables.

· Participate in defect management, test evidence collection, and test execution within defined timelines.

· Ensure all QA documentation meets ALCOA+ and data integrity requirements.

· Participate in risk assessments and ensure testing activities are performed according to approved validation plans.

· Review in change control and regression testing for validated systems.

· Contribute to continuous improvement of testing and QA processes.

· Support audit preparation and inspection readiness activities.

Qualifications & Experience

· Bachelor's degree in Computer Science, Information Technology, Engineering, or related field.

· 3+ years of experience in IT Quality Assurance or Software Testing, preferably in a GxP-regulated environment.

· Basic understanding of CSV principles, GAMP 5 framework, and regulatory requirements (21 CFR Part 11, Annex 11).

· Familiarity with test management tools (e.g., HP ALM, Jira) and documentation systems.

· Understanding of data integrity and good documentation practices.

Skills & Competencies

· Strong attention to detail and documentation accuracy.

· Good analytical, organizational, and communication skills.

· Ability to work collaboratively in a cross-functional, regulated environment.

· Eagerness to learn and develop technical and compliance skills.

· Adaptability to dynamic project timelines and priorities.

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