Empleos en Dorado, dorado

Viatris Pharmaceuticals LLC

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 :

Providing high quality trusted medicines regardless of geography or circumstance;

Advancing sustainable operations and innovative solutions to improve patient health; and

Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here’s how the IT CSV System Analyst role will make an impact :

Key responsibilities for this role include :

Review, assist and in some cases prepare computer system validation deliverables (documentation, testing, and change controls) for computer systems in accordance with relevant regulatory protocols, such as 21CFR parts 11, 210, and 211, aligned to ITQMS policy requirements. Review implementation deliverables to ensure items will meet regulatory and Viatris Standard Operating Procedure requirements.

Participate in gathering the appropriate level of information needed to complete validation documentation. This will require communicating with the proper business, IT and QA personnel to gain the necessary information as well as acquiring proper review and approval activities. This will also require attending and coordinating meetings to complete validation documentation.

Provide validation guidance to implementation teams on an ongoing basis. Create and champion standards for validation process and deliverables. Create and maintain documentation templates to speed the documentation process.

Assist in maintaining schedules for assigned project tasks and coordinating validation tasks (documentation, testing, training, and change controls) with the project manager and team members. Perform follow up on deliverable related tasks with assigned parties. Ability to plan and schedule validation projects. Respond to team members requests for assistance in creating content for validation (documentation, testing, and change controls). As part of project delivery, drive validation workstreams and identify solutions.

Provide management of validation master files, testing project(s), and TrackWise / CMDB CI's including maintaining appropriate controls, quality standards and consistency as required by management. Prepare for planned regulatory authority audits. Respond to requests for access and questions on validation deliverables. Respond to quality audits from internal and external audit constituencies.

Works 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. Must be fully proficient in validation processes in a GMP environment.

Perform Computer System Validation (CSV) functions to meet the goals and objectives of a project. Responsible for development and execution of validation function deliverables to support one (or many) projects to include technical development, validation testing, change management / controls, and documentation (SOP's, validation plans, design specs, protocols, architecture specs, and reports) and training.

Provide project oversight for validation processes and procedures; and implements changes and / or improvements to meet appropriate regulatory requirements, internal policies, and current industry practices. Actively represents Computer System Validation on Project teams globally with respect to the interpretation and application of regulatory requirements concerning validation.

Provide support to the IT and QA 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.

Identify opportunities for continuous improvement of validation philosophy, practice, and procedure to ensure the highest standards.

Provide support to facilitate Initial Risk Assessment and / or functional risk assessment discussions pertaining to CSV. Ensure proper assessments.

Act as a team mentor to other CSV resources and project team members.

Identify and provide updates for IT CSV Policy and SOPs for Document Management, Change Management, and Testing activity.

Assist project teams with CMDB strategy for application set up in Viatris's ITIL tool.

Collaborate with other North America for CSV learning and help implement global Quality / Validation initiatives

Perform other duties as assigned.

The minimum qualifications for this role are :

Requires exceptional technical writing skills.

Must have the ability to create and facilitate all required computer system validation documentation.

Must possess the ability to have strong control over documentation.

Must have the ability to keep current on FDA regulations.

Must possess the ability to enforce standards set forth by Viatris and the FDA.

Validation Practices (CSV) and Standards (such as GAMP 4 & 5).

Technical skills in Microsoft Office Suites.

IT Systems and Automation knowledge.

Knowledge of Documentum or electronic document management practices, tools and applications.

Knowledge in computerized system testing practices, tools and applications.

Knowledge in change management practices, tools and applications.

EDUCATION / EXPERIENCE

Minimum of a bachelor’s degree in engineering or science and / or

Minimum of 4 years of experience in the pharmaceutical industry (or similar industry in Information Systems, Engineering, Technical Services, Production, or related field.)

Combination of experience and / or education will be taken into consideration.

LICENSES / CERTIFICATIONS

Certificate of Completion Accredited and Approved by CIAPR of Regulatory Compliance - (FDA, GMP & GDP, Pharmaceutical Packaging & Manufacturing Process, Data Integrity, Validation)

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.