Quality Engineer Production Support

Mylan Teoranta

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. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

The Quality Engineer Production Support is responsible for generating investigation reports and addressing CAPAs (Corrective and Preventative Action) supporting continuing production, resolution of manufacturing incidents and optimizing operational activities for sterile injectable products. The incumbent will leverage the site cross-functional team members to support these activities and will work closely with the site operations and operational support departments (Engineering/Validation/QA/R&D) teams on-site.

Every day, we rise to the challenge to make a difference and here's how the Quality Engineer Production Support role will make an impact:

• Develop familiarity with site processes & procedures supporting GMP
• Production of sterile injectable products.
• Initiating and completing non-conformance reports (NCRs) as required, coordinating production related NCRs to close in a timely manner.
• Develop CAPAs that satisfactorily address root cause and following through on effective corrective actions to prevent reoccurrence of failures.
• Define/Develop Standard Operating Procedures & batch paperwork for equipment/processes in collaboration with Production personnel that incorporates Operational Excellence principles.
• Ensure that work is carried out safely and in compliance with the organization's quality system. Learn how to generate quality documentation in compliance with the internal organisational procedures and GMP.
• Take ownership and ensure all personally assigned duties are carried out and controlled in line with the internal organization's policies.
• Support operations area projects and initiatives when required.

About Your Skills & Experience

For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• A good understanding of pharmaceutical production and GMP, prior 'hands-on' experience would be a distinct advantage, however this is not a requirement as full training will be provided to the successful candidate.
• Degree/Diploma in relevant Science/Engineering/Manufacturing/Pharmaceutical course (e.g. Manufacturing, Mechanical, Biomedical, Pharmaceutical Operations, etc.), however a combination of relevant work experience and education will be considered.
• Must possess a good working knowledge MS Office Suite.
• Good communication and interpersonal skills
• Good report writing skills
• Good analytical skills with excellent attention to detail.
• Have the ability to work independently, be proactive with a solutions driven approach
• Knowledge in Electronic Records system (Specifically digital Quality Management Systems), Process improvement/design is desirable but not required
• Knowledge of DMAIC/Problem solving tools and Lean Principles is desirable but not required

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Why Viatris?

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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

Viatris is an Equal Opportunity Employer.