Validation Specialist Job

Validation Specialist is needed to perform the following duties:

· Working as a Validation Specialist requires dealing with a variety of tasks and challenges related to Validation, Data Visualizations, Cloud hosted systems e.t.c, by developing audit reports, visualizing testing results and the deviations.

· Leveraging data analytics, to forecast system validation requirements, assess risks, and optimize processes for efficiency.

· Create dashboards for validation tracking, identify potential bottlenecks, and devise strategies to optimize project workflows. This analytical mindset is invaluable in ensuring the efficiency and success of system validation results.

· Utilizing statistical analysis support risk-based validation data, assess performance, and identify areas for compliance enhancement.

· Identify the system control points, deviation trends and perform the Risk-based validation (per GAMP 5/ICH Q9). Apply predictive analysis to equipment calibration intervals and prioritize high-risk areas for validation testing through different analytics methods.

· Validate inputs/outputs of AI algorithms under FDA draft guidance for machine learning in medical systems.
Ensure model training datasets are complete, traceable, and meet GxP data integrity standards

· Automating the compliance metrics of the systems during the validating phase by assisting in real time monitoring of validation tasks, audit-readiness, data integrity checks in the EMS. This automation mindset is particularly valuable in complex projects where multiple tasks need to be managed concurrently.

· Analyzing historical project data and identifying patterns, to anticipate potential project risks, resource constraints, and schedule delays. This proactive approach allows to mitigate risks and implement contingency plans, ensuring project milestones are achieved efficiently.

· Helps assess system-user interactions, ensuring interfaces are user-friendly, logically structured, and compliant with usability standards.

· Supports validation of electronic records and signatures by understanding how users interact with cloud-based or web-hosted platforms. Understanding front-end/backend communication in internet-based systems enables faster diagnosis of software-related issues during validation.

· Internet Computing knowledge helps assess vulnerabilities in web-connected validation systems (e.g., remote access, cloud storage). Utilizing internet-connected sensors, data loggers, and monitoring devices to capture real-time data on critical process parameters, environmental conditions, and equipment performance.

· HCI enables evaluation of user interface clarity, navigation logic, and error feedback, ensuring compliance with usability and data integrity standards. Helps navigate and validate cloud-hosted solutions and portals used for QMS, DMS, and training systems in regulated environments.

· Effective communication, document sharing, and version control among team members, streamlining the validation process and ensuring consistency in documentation and execution. Facilitating the virtual meetings, training sessions, and knowledge sharing forums, enabling validation teams to exchange best practices, resolve issues, and align on validation strategies efficiently.

· Leading and managing multiple CQV projects for large scale Pharma industries. Implement project management methodologies such as scrum and agile to ensure timely delivery and successful completion of projects.

· Help the project team with the design and development tasks including but not limited to URS, FS, CS, RTM etc.

· Leading the process of issue identification and resolution using Risk based project management approach and techniques.

· Owning the project schedule and meet 100% deadlines by proactively identifying and mitigating any risks.

· Monitoring and managing the project scope along with project documentation.

· Reporting leadership and team on project progress and offering viable solutions and opportunities to issues and risks as they arise.

Bachelor's Degree is required in Computer Science or Computer Engineering or Information Science & Technology.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave