Senior QA Executive (Packaging)

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 Senior QA Executive (Packaging) role will make an impact:

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• Manage core competencies activities of the team.
  
• Quality Management Systems: Support and ownership of Investigations, CAPA & LIRs, Trend Assessments, Risk Assessment, Customer Complaints, Supplier Non-Conformances (PMSI’s), Management review implementation.
  
• SOP review/input for packaging and warehouse department for compliance to Guidance and Global Policy and maintaining the revision on GMP documentation within the team.
  
• Act as Subject Matter Expert in Quality for packaging and warehouse departments.
  
• Oversee QA processes including but not limited to line clearance, incoming inspection, artwork updates and approval, batch paperwork review and issuance.
  
• Create, maintain and deliver training in quality related topics to Viatris personnel.
  
• Support the Quality Assurance team in preparation of monthly/quarterly/annual reports to be submitted to senior management and Viatris departments to ensure visibility of QMS requirements and performance including the compilation of quality metrics to facilitate monitoring and management of the Viatris Quality System.
  
• Work with cross functional teams as required to implement global quality policies and compliance improvement initiatives as they relate to pharmaceuticals and medical devices and site quality model; challenge areas of technical compliance with responsible parties.
  
• Participate in site Internal audit program and support external and regulatory inspections as required.
  
• Provide technical compliance guidance and support in relation to all products as required to all personnel at the site.
  
• Support the quality organization to meet the needs of the growing business; using technical expertise, skills knowledge and experience as required to resolve problems and share knowledge.
  
• May act as principal project quality lead for new and existing Mylan projects/introduction of new technology, providing advice and guidance to operational teams with the support and guidance from the Quality Manager.
  
• Manage and mentor more junior members of the team as required.
  
• Act as Manager approver in absence of Manager as requested.
  
• Perform other duties as assigned.
  

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• Experience with management of QMS. Experience in either a Quality Assurance, Validation or Regulatory Affairs role essential.
  
• Ability to handle multiple tasks in a fast paced environment.
  
• Experience of Quality Operations and Lean operational systems in manufacturing is beneficial.
  
• Experience of new equipment introduction/qualification is beneficial.
  
• Working knowledge of DMAIC, 6-Sigma management tools, statistical analysis and trending.
  
• Bachelor’s degree (or equivalent) in a Science related discipline.
  
• 8+ years in Pharmaceutical/ Medical Device Quality Assurance/Control or related department.
  
• Previous experience in a sterile product manufacturing and or packaging facility.
  
• A combination of experience and/or education will be taken into consideration.
  
• Positive attitude with an innovation mindset.
  
• Self-starter with demonstrated efficient work methods and excellent initiative.
  

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. xcfaprz

Viatris is an Equal Opportunity Employer.