Validation Reviewer Ii
2 weeks ago
Leads validation projects as assigned and serve as a validation team member on multiple assignments as designated by the management with support from other team members as needed.
- Serve as a member of the project team with primary responsibility for all documentation requirements in support of Global EDC Solutions tasks to include creating, reviewing and executing of validation documentation.
- Review Scope of work for the assigned project.
- Manage validation documentation packages including the Validation Plan, Testing Results, Traceability Matrix, and Validation Report.
- Assist project teams with validation tasks as requested, i.e., with the creation, production, printing and tracking of study documentation and controlled documents.
- Provide coordination of virtual global validation teams as needed to complete validation projects.
- Maintains and utilizes a strong knowledge of SOPS and validation work procedures/standards in relation to the Validation tasks.
- Demonstrate the ability to multi-task and manage validation activities for a project effectively.
- Plan and establish timelines to meet or exceed client expectation for validations.
- Review clinical project specification documentation to create appropriate testing methodologies.
- Act as Subject Matter Expert (SME) and be point of contact for any technical services, issues related to Validation process.
- Write and review validation documentation to support projects.
- Work with other team members to create appropriate testing environments to support testing methodologies.
- Conduct Peer Review/Quality control of study design for assigned projects
- Utilize strong working knowledge of SOPs, validation standards, and work procedures to suggest potential improvements and to provide training and guidance to all critical staff.
- Assist in the support of regulatory and client audits of validation activities and documents.
- Support management of metrics.
- Assist with investigating or resolving issues of patient safety or quality as directed.
- Understand implications of activities on project budgets.
- Suggest process improvements at various levels of validation process.
- Assist in developing key metrics for process improvement.
- Train, Mentor and support the team in their understanding and adoption of validation concepts and responsibilities.
- Active member of SOP review team as assigned.
- Lead or assist with special projects as designated.
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