Senior Quality Assurance Executive (QOO)

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 Senior Quality Executive (QOO Affiliates) is responsible for providing Quality and Regulatory Compliance Technical Input to Third Party organizations contracted to develop manufacture, release / or supply Sterile injectable product, ophthalmic products and medical devices to Mylan Institutional for the US Market.  The role will provide systematic overview of third party manufacturing operations to ensure compliance and state of control through frequent and extensive on-site & off site assessment, and leading corrective & preventive action plans as needed in response to quality indicators to ensure a continuous state of GxP compliance

Every day, we rise to the challenge to make a difference and here’s how the Senior Quality Executive (QOO Affiliates) role will make an impact: 

• Quality Management Systems: Oversee Complaints, Escalations, FAR, Investigations, OOS, CAPAs; manage Internal Audit Programme.

• Vendor Management: Support Vendor/TPM approval, risk assessments, audit scheduling, and preparation of Technical and Confidentiality Agreements.

• Product Technical Transfer: Act as SME for product development and launches; support data collation for Technical Transfer, Process Validation, and stability protocols.

• Batch Review Coordination: Manage TPM batch reviews, approve investigations, laboratory OOS, non-conformances, and CAPAs; review Product Quality Reviews.

• Deputy Responsible Person (RP): Manage authorized activities and control Wholesale Distribution, ensuring compliance with EU GDP for medicinal products.

• Deputize for QA Manager (QOO Affiliates) as required.

• Perform other duties as assigned. 

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: 

• Bachelor’s degree (or equivalent) in a Science related discipline with 6+ years in Pharmaceutical/ Medical Device Quality Assurance/Control or related department is essential.

• Experience of sterile injectable manufacturing and third party site quality management desirable but not essential

• Knowledge of Quality Control testing, Advanced knowledge of chemistry, previous HPLC experience (preferably with Empower software) is essential. Experience in troubleshooting within a QC laboratory background is desirable.

• Knowledge of Validation and Aseptic manufacturing an advantage but not essential.

• Knowledge of Pharmaceutical QMS Systems.

• Knowledge of Quality Risk Management Systems.

• Knowledge of cGMPS i.e., USFDA, 2003/94/EC, MHRA and WHO.

• Knowledge and experience in the use of Data Sharing Software Packages an advantage 

• Computer skills i.e., Microsoft Office, Windows etc. Experience in Trackwise, LIMS & SAP would be advantage

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. 

Benefits at 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. Some of our benefits include the following on top of a competitive salary: 

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  

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.