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
Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Specialist role will make an impact:
Development and leadership of a core team of QC Analysts, which includes mentoring, training, appraising performance and supporting individual Development Plans.
Schedule, Co-ordinate & Supervise all analytical activities within the QC Laboratory ensuring all activities are carried out in a timely manner to meet company objectives and relevant key performance indicators.
Co-ordinate efficient and robust QC sampling routines covering API, utilities, final product and method transfers with timely production of relevant QC Documentation including Protocols, Reports, Analytical data sheets, SOPs, change controls, deviations and IRF’s
Review and approve non-chromatographic and chromatographic data. Review and approve filled product, raw material and stability analytical data sheets in a timely manner to meet company objectives. Support QA personnel in close out of QC batch release and stability program issues
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. Compilation of technical reports to support laboratory investigations, qualifications, trend evaluations
Lead the chromatography and wet chemistry training of QC analysts
Management of QC SOPs, change controls, deviations, CAPAs and lab investigations. Ensure cGMP compliance is maintained in the QC laboratory at all times.
Co-ordinate instrument calibrations & maintenance and qualification to specified schedules.
Support continuous improvement projects such as 6S and lean processes for the laboratory. Participation in internal audit and laboratory walkthrough programs and represent the QC laboratory in third party inspections as required Provide input to regulatory files in support of new product submissions and approvals.
Act as Designee/Deputy for 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 7 years of relevant industrial experience.
Previous HPLC/GC/Peptide analysis experience in method validation / transfer (preferably with Empower software) is essential.
Strong working knowledge of chemistry / biochemistry (chromatographic, wet chemistry and peptide analysis) techniques.
Empower, LIMS and other lab software systems.
Computer skills (MS Office, Trackwise, Minitab
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:
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 offercompetitivesalaries, benefitsandan 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.