CSV Analyst

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

• Access - Providing high quality trusted medicines regardless of geography or circumstance;

• Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and

• Partnership - Leveraging our collective expertise to connect people to products and services.

Job title: CSV Analyst

Company: DPT Laboratories, Ltd., a Mylan company (San Antonio, Texas)

Duties: Review, assist, and prepare computer system validation deliverables such as documentation, testing and change controls for computer systems in accordance to relevant regulatory protocols such as 21CFR parts 11, 210 and 211. Review implementation deliverables to ensure items will meet regulatory and Viatris/DPT standard operating procedure requirements. Collaborate and learn new automation and computer systems in order to serve the CSV liaison for systems. Participate in gathering the appropriate level of information needed to complete validation documentation which will require communicating with the proper business, IT and QUALITY personnel to gain the necessary information as well as acquiring proper review and approval activities. Provide validation guidance to implementation teams on an ongoing basis. Create and champion standards for validation process and deliverables. Assist in maintaining schedules for assigned project tasks and coordinating validation tasks such as documentation, testing, training and change controls with the project manager and team members. Provide management of validation master files, testing projects, and Trackwise CMDB CI's including maintaining appropriate controls, quality standards and consistency as required by management. Prepare for planned regulatory audits, respond to requests for access and questions on validation deliverables, and respond to quality audits form internal and external audit constituencies. Work independently as the validation workstream representative to ensure new and or revised software, equipment, processes and or procedures are validated in accordance with regulatory standards and company policies and procedures. Perform Computer System Validation functions to meet the goals and objectives of a project. Responsible for the development and execution of validation function deliverables to support one or many projects to include technical development, validation testing, change management/controls and documentations such as SOP's, validation plans, design specs, protocols, architecture specs and reports and training. Actively represent Computer System Validation (CSV) on project teams globally with respect to the interpretation and application of regulatory requirements concerning validation. Provide support to the IT and QUALITY organizations and project teams to ensure harmonized and consistent use of CSV standards, templates, and procedures for computer system validation for Enterprise systems with focus on GMP/ regulated systems and technologies. Provide support to facilitate Initial Risk Assessment and or functional risk assessment discussions pertaining to CSV to ensure proper assessments. Identify and provide updates for IT CSV policy and SOPs for document management, change management and testing activity.

Requirements: Bachelor's degree or foreign equivalent in Computer Science, Information Technology, or related field and 2 years of experience in the position offered or related. Must have 2 years of experience with: creating and facilitating all required computer system validation documentation; working with validation practices (CSV) and standards such as GAMP 4 & 5; working electronic document management practices, tools, and applications, including Documentum, D2, SharePoint, Sparta Systems, and TrackWise; working with computerized system testing practices, tools, and applications, including Selenium, GAMP 5, and SOP; and working with change management practices, tools, and applications, including TrackWise and ServiceNow.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.