Want to know if this job is worth applying to?
Indreabhán, Éire / Ireland
Onsite
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on number of award lists that demonstrate the impact we are making.
This posting supports ongoing hiring needs and may be used to consider candidates for upcoming opportunities.
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
As Quality Control (QC) Technical Transfer Analyst, you will support the delivery of 3-year commercialization program for a new cartridge-filling product line and will be primarily responsible for the transfer of advanced chromatographic and wet chemistry analysis of raw materials, finished product and stability product samples in support of new product introduction, and completing the relevant GMP documentation
Every day, we rise to the challenge to make a difference and here’s how the Quality Control (QC) Technical Transfer Analyst role will make an impact:
Lead new method transfers to the QC lab and drive the timely performance of complex analytical and chromatographic testing of raw materials, finished product, stability samples, for products being transferred from Product Development on site or from external sites.
Source and procure all equipment, materials and consumables associated with product transfer methods in a timely manner to ensure analytical work can be executed in line with project plans and day 1 launches.
Operate as the subject matter expert (SME) in the area of chromatography, and other areas related to analytical techniques, GMP execution, and become the point of contact for technical and troubleshooting assistance to the QC team.
Liaise with cross functional teams such as analytical development, manufacturing and regulatory affairs to ensure method transfer deliverables are understood and communicated within the QC team.
Co-ordinate and supervise laboratory investigations to ensure they are captured, documented and actioned with close out in an effective and timely manner.
Take a senior analytical role within new projects, the analytical lead position, and drive the project towards timely and successful completion.
Compilation of technical reports to support analytical transfers, laboratory investigations, qualifications, trend evaluations.
Establish chromatography and wet chemistry training plans for QC analysts to ensure robust and compliant execution of analytical methods and to familiarize Quality reviewers with critical test method attributes.
Management of QC SOPs, change controls, deviations and IRFs associated with New Product transfers activity in QC laboratory.
Work closely with the stability program coordinator to ensure new products are placed on stability and that all elements of New Product test methods and specifications are in place for start of program
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) relevant industrial experience. Previous HPLC/GC/ peptide analysis experience in method validation / transfer (preferably with Empower software) is essential.
Must possess strong working knowledge of chemistry / biochemistry (chromatographic, wet chemistry and peptide analysis) techniques.
Strong technical trouble shooting and writing skills.
Empower and other lab software systems.
cGMP
Computer skills (MS Office, Trackwise, Minitab).
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.