Investigation Specialist

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:

• 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 Investigation Specialist role will make an impact:

Key responsibilities for this role include:

The Investigations Specialist is responsible for activities related to the investigations/deviations/CAPA process. Responsibilities include conducting the investigations, writing summary reports, suggesting, and implementing appropriate corrective actions, and verifying effectiveness of CAPA.

The minimum qualifications for this role are:

• Write investigations (QARs and event reports) related to manufacturing, bulk packaging, warehouse, facility and engineering, stability (Quality Notification Reports, QNRs), internal and external complaints etc. Conduct Root Cause Analysis (RCA) to evaluate each of the possible causes in order to determine the true root cause. Propose appropriate corrective actions and preventive actions (CAPAs) as well as CAPA effectiveness checks.

• Complete investigations within established time frames. 

• Evaluate incidents and submit for QA review.

• Lead investigation meetings.

• Complete assigned CAPAs within established time frames.

• Engaging subject matter experts to assist in investigations as applicable.

• Assist management during FDA audits with respect to investigations and CAPAs.

• Communicates as appropriate with other Pfizer Sites and suppliers.

• Communicate status of investigations and escalation issues as appropriate.

• Use Operational Excellence tools (M1 to M4) as part of troubleshooting and investigation process.

• Assist in the development of policies, procedures, and protocols for investigation-related practices.

Education

• Bachelor’s degree in pharmacy, Engineering, or Science.

Experience

• 2 to 4 years of related manufacturing/packaging experience.

• Strong knowledge of cGMPs.

• Strong knowledge of Operational Excellence (OPEX) tools (Green Belt or Black Belt is a plus).

• Knowledge of Trackwise (QTS), EAMS, PDOC’s, Plateau, SAP.

Other requirements

• Technical Skills

  • Technical writing.

  • Analytical skills.

  • Computer Literacy.

  • Strong knowledge of manufacturing and packaging processes and equipment.

  • Working knowledge of Microsoft Word, Excel and PowerPoint.

• Fully bilingual Spanish and English (verbal/written).

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.