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.
Every day, we rise to the challenge to make a difference and here’s how the Quality Systems Analyst I role will make an impact:
Key responsibilities for this role include:
Responsible for providing guidance and feedback to both internal and external customers to ensure Quality Systems requirements are met.
Support site documentation management program including implementation and obsoleting of documentation as a D2 systems coordinator.
Review of Change Controls to include facilitating change control records and their associated action items for implementation and closure.
Support computerized system audit trail reviews.
Support site and Global TrackWise systems as Superuser.
Assist in the drafting of annual product reports.
Assist in the drafting of complaint trending reports.
Review of Quarterly Quality Control trending reports.
Review of equipment and cleaning validation protocols and reports.
Support drafting, routing, and approval of executed Confidential Disclosure Agreements and Quality Agreements.
Issuance of documentation and logbooks for product manufacturing, packaging, and testing.
Support review and approval of calibration certifications, out of tolerance assessments (OOT) and/or OOT deviations.
Provide support for maintaining weekly/monthly internal Quality metrics.
Support internal, client, and regulatory audit requests as required.
Within area of responsibility, understand and comply with all safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state, and local regulations.
Perform other duties as assigned.
The minimum qualifications for this role are:
Bachelor’s degree from an accredited four-year college or university is required.
Minimum 0-2 years of industry related experience is required with a Bachelor’s degree; or equivalent combination of education and experience with minimum 10 years of Quality experience. Pharmaceutical, medical device and/or manufacturing industry experience is required.
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.