Senior Quality Assurance Officer

9 months ago

Sandwich, United Kingdom Viatris Full time

Mylan Pharma UK Limited

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

As Senior Quality Assurance Officer you will be required to ensure that the Pharmaceutical Quality System is embedded into the MPUK (Viatris) organisation and is efficiently executed, maintained and improved. To provide GMP QA support for global clinical studies, supporting GMP manufacturing, packaging, testing, storage and distribution, and QA support for internal R&D projects. To lead support for studies, projects, Quality initiatives or parts of the Pharmaceutical Quality System. To manage the quality oversight of MPUK external vendors.

Every day, we rise to the challenge to make a difference and here’s how the Senior Quality Assurance Officer role will make an impact:
- To assist in the development and maintenance of specific quality areas/systems within manufacturing, packaging, analytical testing, clinical supply, storage, distribution, and the science and technology development processes.- To perform manufacturing and packaging batch record reviews, and prepare documentation for batch disposition.- To assist in the creation, maintenance, review and approval of SOPs as required, ensuring alignment between business lines and MGRG sites, and compliance with current regulations.- To support the development and maintenance of the training system.- To support the development and maintenance of documentation controls.- Manage Quality Investigations, CAPAs, Out of Specification Investigations, Change Controls and complaints, ensuring GMP compliance is maintained.- To perform internal Quality inspections.- To represent Quality Assurance in discussions and action plans for assigned clinical studies and R&D projects.- To manage the oversight of external vendors to support GxP operations. To ensure activities are carried out as required, and that clear roles and responsibilities are defined.- To lead projects, Quality initiatives or parts of the Pharmaceutical Quality System. This may include multiple business lines within the organisation, and may include other Viatris sites or external vendors.- To ensure activities are carried out in compliance with Viatris Global policy and regulatory expectations.

About Your Skills & Experience- Bachelor’s degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) and/or technical discipline OR relevant experience (as below).- To be able to lead projects or Quality initiatives with limited supervision. This may include multiple business lines within the organisation, and may include other Viatris sites or external vendors.- Demonstrate frontline experience in pharmaceutical drug product QA/QO, OR manufacturing, OR drug product/analytical development.- Have a clear understanding of the principles and challenges of pharmaceutical GMP.- Be able to lead technical problems / challenges to clear resolutions.- Have strong organisational skills, and to be able to work in a structured, logical, articulate, clear and concise manner.- To be able to work autonomously with limited supervision.- To have effective verbal and written communication skills, including the ability to work effectively with external vendors, such that Quality oversight can be maintained.

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:
- Top Employer Accreditation, demonstrating that we provide excellent people policies and practices- Competitive compensation package inclusive of annual discretionary bonus- Focus on career progression with growth and development opportunities- Hybrid work model- Emphasis o

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