Quality Assurance Compliance Specialist

2 weeks ago

Greensboro, United States Viatris Full time

Company Overview: Mylan Pharmaceuticals Inc.

At VIATRIS, we envision healthcare not merely as it exists but as it ought to be. We act with conviction and are uniquely positioned to provide stability in a landscape of changing healthcare demands.

Viatris empowers individuals globally to lead healthier lives at every stage.

We achieve this through:

  • Access: Delivering high-quality, trusted medications irrespective of location or circumstance;
  • Leadership: Promoting sustainable practices and innovative solutions to enhance patient health; and
  • Partnership: Utilizing our collective expertise to connect individuals with products and services.

Role Impact: Every day, we rise to the challenge of making a difference, and the Quality Compliance Associate position plays a crucial role in this mission.

Key Responsibilities:

  • Assist in the coordination, completion, and documentation of site incidents, investigations, complaints, and CAPA records to ensure timely resolution of related activities.
  • Support the activities linked to the site's data integrity document control and disposition tasks.
  • Facilitate operations related to the performance of the site's internal inspection program.
  • Review and/or amend SOPs and Work Instructions concerning internal and/or external inspections and incidents.
  • Gather and report metrics related to inspections and incident investigations for the site Quality Council.
  • Provide quality support during audits and inspections conducted by clients, health authorities, and/or regulatory bodies.

Minimum Qualifications:

  • A Bachelor's degree (or equivalent) and 1-2 years of experience in the pharmaceutical sector, with knowledge of distribution, investigation, and auditing practices. A combination of experience and/or education will be considered.
  • Familiarity with domestic and international good manufacturing and good distribution regulations relevant to Distribution Center Operations and the storage and distribution of pharmaceutical and medical device products, along with good documentation practices.
  • Understanding of inspection and investigation processes associated with good distribution practices.
  • Knowledge of Drug Supply Chain Security Act requirements concerning the serialization of pharmaceutical distribution.
  • Excellent written and verbal communication skills, along with strong interpersonal, problem-solving, and organizational abilities.
  • Attention to detail and accuracy are essential.
  • Proficient computer skills, including Microsoft Office Applications (i.e., Word, Excel, and PowerPoint). Experience with electronic document control, event management, and inventory control systems such as D2 Documentum, TrackWise, and SAP is preferred.
  • Proficiency in English, including speaking, comprehension, reading, and writing.

Company Culture: At Viatris, we offer competitive salaries, benefits, and an inclusive environment where you can leverage your experiences, perspectives, and skills to make a meaningful impact on the lives of others.

Equal Opportunity Employer: 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.

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