QA Specialist Annual Product Review

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 Assurance Specialist role will make an impact:

Key responsibilities for this role include:

Responsible for the issuance of the Annual Product Review (APR), performing activities including but not limited to preparation of the yearly schedule, gathering of complaints, analytical and in-process

data, and product changes. Perform statistical analysis of the laboratory analytical and in-process data. Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal

and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.

Essential Duties and Responsibilities

• Issues Annual Product Record Review (APR) Vega Baja site products as established in yearly schedules.

• As part of the APR, evaluate data and make recommendations, as needed.

• Prepares trending studies to avoid quality problems and make recommendations for corrective actions.

• Support Inspections readiness processes.

• Be able to work in QA or QO depending on business needs and/or reassignment of responsibilities.

• Alerts Management of compliance issues.

• Performs special project assignments as required.

• Reviews and approves Standard Operation Procedures.

• Follows notification to management process/procedures for any quality and safety issues.

• Ensures that Quality documentation and systems are following data integrity principles.

• Ensures Controlled Substances are managed according to DEA regulations and follow internal SOPs.

• Perform other duties as assigned by the Supervisor.

Education/Experience

Education:

• BS Degree in Science (Chemistry, General Sciences, Biology), Statistical, or Engineering.

Experience/Knowledge:

• At least five (5) years of experience in the pharmaceutical industry with similar responsibilities.

• Good Statistical knowledge and experience working with laboratory, manufacturing and/or packaging processes.

• Experience handling and/or supporting regulatory inspections.

• Knowledge of GMP, NDA, CMC, and DEA/FDA regulations.

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.