QC Data Reviewer

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 Control Data Reviewer will be primarily responsible for the review of chromatographic and wet chemistry analysis of raw materials, in-process, finished product and stability product samples and completing the relevant GMP documentation.

Every day, we rise to the challenge to make a difference and here’s how the Quality Control Data Reviewer role will make an impact:

• Review and approve wet chemistry, non-chromatographic and chromatographic data for raw materials, in-process, finished product and stability products.

• Conduct routine chromatographic (HPLC and GC) analysis of raw materials, in process, finished product and stability samples in strict compliance with GLP & cGMP procedures. 

• Assist in the transfer (and troubleshooting, where required) of analytical methods to the QC laboratory as and when required.

• Co-ordinate and supervise laboratory investigations to ensure they are captured, documented and actioned with close out in a timely manner. Ensure OOS results are escalated and where relevant FARs are required they are initiated within the required timeline.

• Support continuous improvement projects such as 6S and lean processes for the laboratory.

• Assist in chromatography and wet chemistry training of other QC analysts.

• Present as subject matter expert during third party inspections as required.

• Management of QC SOPs, change controls, deviations and IRFs.

• Participate in department projects, as assigned by QC Team Lead/QC Manager

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:

• Minimum of a Bachelor's degree (or equivalent) in a Science related discipline ( Chemistry, Biochemistry or Analytical science) and 5-7 years of relevant industrial experience. Previous HPLC/GC/ peptide analysis experience in method validation / transfer (preferably with Empower software) is essential. However, a combination of experience and/or education will be taken into consideration. 

• Strong working knowledge of chemistry / biochemistry (chromatographic, wet chemistry and peptide analysis) techniques.

• Strong technical writing skills.

• Empower and other lab software systems & cGMP

• Computer skills (MS Office, Trackwise, Minitab, LIMS).

• Strong analytical skills with excellent attention to detail.

• Strong technical writing skills

• Communication skills both verbal & written with good time management skills.

• Ability to work as part of a team.

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:

• Excellent career progression opportunities

• Work-life balance initiatives

• Bonus scheme

• Health insurance

• Pension

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.