Job Role: Computer System Management

Experience: 2years to 5 Years

Notice Period: Immediate to 15 Days

Work Mode: WFO

Location: Hyderabad

Preferred Fields of Study:Computer and Information Science, Information Technology, Management Information Systems, any degree or equivalent in Life sciences. Having the medical domain knowledge is a plus.

Responsibilities:· Team Leadership: Lead, mentor, and manage a team of QA and QA Engineers, fostering a culture of quality and continuous improvement.

· Quality Assurance: Oversee all aspects of quality assurance including establishing metrics, applying best practices, and developing new tools and processes to ensure quality goals are met.

· Compliance: Ensure all software solutions are developed in accordance with GxP guidelines and regulatory requirements.

· Computer System Validation (CSV): Implement and manage CSV processes to ensure that all computer systems are validated and meet regulatory standards like 21 CFR Part 11, EU Annex 11, GAMP 5, ISO 9001 / ISO 27001 (if applicable), Positive Documentation Practices (GDP), GAMP guidance related to AI/ML and computerized systems.

· Act as QA representative during customer onboarding and implementation projects.

· Support regulatory submissions and customer compliance questionnaires.

· Participate in management review meetings and quality metrics reporting.

· .Exposure to tools like JIRA, confluence, eQMS Platforms, Cloud SaaS platforms etc.,

· Understanding of AI/ML applications in regulated life sciences environments.





· Knowledge of AI governance frameworks and risk-based validation approaches for AI-enabled systems.

· Collaboration: Work closely with cross-functional teams including development, operations, and product management to integrate QA processes seamlessly into the product lifecycle.

· Testing Strategy: Develop, implement, and maintain comprehensive testing strategies for all phases of software development, from design to deployment.

· Defect Management: Track, manage, and report on software defects, ensuring timely resolution and continuous improvement.

· Process Improvement: Identify and implement improvements in the QA process to enhance efficiency, effectiveness, and accuracy.

· Documentation: Maintain detailed documentation of QA processes, test plans, and test cases to ensure traceability and compliance.

· Oversee and manage quality management systems such as change management, deviations, and CAPA (Corrective and Preventive Actions).

Requirements:

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

· Minimum of 3 years of experience in quality assurance, with at least 2 years in a managerial role.

· Strong knowledge of GxP guidelines and regulatory requirements.

· Experience with Computer System Validation (CSV) processes.

· Proficient in QA methodologies, tools, and processes.

· Excellent leadership, communication, and organizational skills.

· Experience with Agile/Scrum methodologies is a plus.

· Ability to work collaboratively with cross-functional teams).

📌 Computer System validation Engineer (CSV) (Hyderabad)
🏢 Quartica
📍 Hyderabad