Quality Compliance Specialist

7 days ago


Greensboro, United States Viatris Full time
About the Role

Viatris is a global healthcare company that empowers people worldwide to live healthier at every stage of life. We are seeking a highly skilled Quality Compliance Associate to join our team.

Key Responsibilities
  • Incident Management: Support the coordination, completion, and documentation of site incident, investigation, complaint, and CAPA records to ensure timely closure of associated activities.
  • Data Integrity: Support the activities associated with the site's data integrity document control and disposition activities.
  • Internal Inspections: Support the operations related to the performance of the site internal inspection program.
  • Policy Development: Review and/or revise SOPs and Work Instructions as they relate to internal and/or external inspections and incidents and investigations.
  • Metrics Reporting: Collect and report metrics associated with inspections and incident investigations for site Quality Council.
  • Quality Support: Provide quality support during audits and inspections performed by customers, health authorities, and/or regulatory agencies.
Requirements
  • Education: Minimum of a Bachelor's degree (or equivalent) and 1-2 years of experience in the pharmaceutical industry with knowledge of distribution, investigation, and auditing practices.
  • Knowledge: Must possess knowledge of domestic and international good manufacturing and good distribution regulations as they relate to Distribution Center Operations and the storage and distribution of pharmaceutical and medical device products, as well as good documentation practices.
  • Skills: Must possess excellent written and oral communication skills, interpersonal, problem-solving, and organizational skills. Must be accurate and pay meticulous attention to detail. Must possess strong computer skills and be proficient in Microsoft Office Applications (i.e., Word, Excel, and PowerPoint). Experience and knowledge of electronic document control, event management, and inventory control systems such as D2 Documentum, TrackWise, and SAP is preferred.
  • Language: Proficiency in speaking, comprehending, reading, and writing English is required.
About Viatris

Viatris is an Equal Opportunity Employer. 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.


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