CSV Analyst
Viatris
Full-time
Remote friendly (San Antonio, TX)
United States
IT
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Role Summary
CSV Analyst at DPT Laboratories, Ltd., a Viatris company. Responsible for reviewing, assisting, and preparing computer system validation deliverables in accordance with regulatory protocols; providing validation guidance; maintaining validation master files; coordinating validation tasks; and representing CSV on project teams globally to ensure validation compliance.
Responsibilities
- Review, assist, and prepare computer system validation deliverables such as documentation, testing, and change controls.
- Ensure items meet regulatory and standard operating procedure requirements.
- Collaborate with business, IT, and QUALITY personnel to gather information and obtain reviews and approvals.
- Provide validation guidance to implementation teams and create/ champion standards for validation processes and deliverables.
- Maintain schedules for validation tasks and coordinate tasks with project managers and team members.
- Manage validation master files, testing projects, and TrackWise CMDB CI’s with proper controls and quality standards.
- Prepare for regulatory audits and respond to requests related to validation deliverables and quality audits.
- Represent CSV on project teams and ensure validated status of software, equipment, processes, and procedures.
- Support IT and QUALITY teams to harmonize CSV standards, templates, and procedures for enterprise systems with focus on GMP/regulatory systems.
- Assist with risk assessments related to CSV and update IT CSV policy and SOPs for document management, change management, and testing activity.
Qualifications
- Required: Bachelor’s degree or foreign equivalent in Computer Science, Information Technology, or related field; 2 years of experience in computer system validation and related activities.
- Required: 2 years of experience with: creating and facilitating validation documentation; CSV practices and standards (GAMP 4 & 5); electronic document management tools (Documentum, D2, SharePoint, Sparta Systems, TrackWise); computerized system testing tools (Selenium, GAMP 5, SOP); change management tools (TrackWise, ServiceNow).
Skills
- Computer System Validation (CSV) expertise
- Regulatory compliance knowledge (GMP, 21 CFR parts 11, 210, 211)
- Documentation management and change control
- Project coordination and cross-functional collaboration
- Proficiency with TrackWise, ServiceNow, Documentum, D2, SharePoint, Sparta Systems, Selenium
Education
- Bachelor’s degree or foreign equivalent in Computer Science, Information Technology, or related field
Additional Requirements
- Travel not specified
- No other physical demands specified