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Quality Compliance Associate

2 months ago

Greensboro, United States Viatris Full time

Mylan Pharmaceuticals Inc.

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 Compliance Associate role will make an impact:

Key responsibilities for this role include:

  • Support the coordination, completion and documentation of site incident, investigation, complaint, and CAPA records to ensure timely closure of associated activities.

  • Support the activities associated with the site's data integrity document control and disposition activities.

  • Support the operations related to the performance of the site internal inspection program.

  • Review and/or revise SOPs and Work Instructions as they relate to internal and/or external inspections and incidents and investigations.

  • Collect and report metrics associated with inspections and incident investigations for site Quality Council.

  • Provide quality support during audits and inspections performed by customers, health authorities and/or regulatory agencies.

The minimum qualifications for this role are:

  • 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. However, a combination of experience and/or education will be taken into consideration.

  • 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.

  • Must possess knowledge of inspection and investigation processes associated with good distribution practices.

  • Must possess knowledge of Drug Supply Chain Security Act requirements as it relates to the serialization of pharmaceutical distribution.

  • 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.

  • Proficiency in speaking, comprehending, reading, and writing English 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.