COMPUTER SYSTEM VALIDATION

JOB ROLE: Computer System Validation (CSV)

Experience: 3 Years tO 5 Years

Notice Period: Immediate To 15 days

WOrk mOde: On_SIte

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

·        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), Good 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 5 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).

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