Job Summary

• 6+ years’ experience in Computer System Validation or Quality management or Business Analysis in GxP application area
• Responsible to Author Validation Deliverables which includes - Validation / Compliance Plan, Report, RTM,  Data Flow Map, Change Controls etc.
• Developing validation strategy for projects
• Good Knowledge on Requirement Analysis and UAT Authoring
• Providing audit support and support Application Lifecycle Management
• Managing/guiding/overseeing periodic checks
• Ability to guide cross-functional teams and mentor junior staff
• Broad experience in Computer System Validation (CSV) and testing
• Acquainted with Good Clinical Practices (GCP) regulatory requirements and FDA 21 CFR Part 11
• Clear written and verbal communication, especially for technical documentation
• Acquainted with both the agile and waterfall software development methodology
• Solid understanding of the fundamentals of iterative and incremental software development
• Proficiency in tools like JIRA, qTest, SNOW and/or other validation tracking systems
• Skilled in project planning, execution and minimal rework strategies
• Capable of risk identification and mitigation, especially in regulated environments
• Strong Analytical and Problem solving

Key Responsibilities

1. To develop and deliver ,detailed solutions through consulting project activities
2. To perform qualitative and/or quantitative analyses to assist in the identification of client issues and the development of client-specific solutions
3. To coordinate with Internal and external stakeholders to ensure effective deliver of client specific solution
4. To design,structure and deliver reports and presentations that are appropriate to the characteristics or needs of the audience
5. To cultivate successful customer relationships

Skill Requirements

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Other Requirements

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