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:
Responsible for activities related to manufacturing and packaging deviations’ investigation process. Responsibilities include conducting the investigations, writing summary reports, and identifying appropriate CAPA to avoid recurrence.
Key responsibilities for this role include:
Perform and document Investigations (Investigations or Incident Reports) related to manufacturing, packaging, warehouse, facility and engineering, stability results, internal and external complaints, etc. Conduct Root Cause Analysis to evaluate each of the possible causes to determine the true root cause.Propose appropriate and sustainable corrective actions and preventive actions (CAPAs).
Complete investigations and assigned CAPAs within established time frames.
Lead investigation meetings, M1 or any other meeting as required.
Engaging subject matter experts to assist in investigations as applicable.
Assist management during FDA audits with respect to investigations and CAPAs.
Develop protocols for emptying, inspection, and/or repackaging of lots associated to investigations.
Support operation’s areas on the generation of Change Request required as part of an investigation.
Communicates as appropriate with other Viatris 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.
Assist operation’s areas in the evaluation of deviations or atypical incidents identified during production. Coach operation’s supervisors on the documentation of the evaluated incidents in Trackwise system.
The minimum qualifications for this role are:
Education
Minimum of a bachelor’s degree in pharmacy, engineering, or science.
Experience
2 to 4 years of related manufacturing and/or packaging experience.
Skills
Knowledge
Must possess strong knowledge of:
Manufacturing and packaging processes and equipment.
cGMPs.
RFT tools (Green Belt or Black Belt) is a must.
Trackwise, SAP.
Skills and Abilities
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.
Abilities/ Competencies.
Managing multiple priorities.
Communication skills.
Negotiation skills.
Leadership.
Innovation and creativity
Strategic thinking.
Problem solving.
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.