Quality System Specialist

Viatris; Dublin; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Excellent career progression

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris is a global healthcare company delivering branded and generic medicines worldwide. The Quality System Specialist role focuses on review of GxP documentation, product complaints, change controls, PMSI and CAPA implementation, and maintaining QTAs with suppliers to ensure GDP/compliance.

The candidate will manage product returns, vendor approvals, and annual supplier reviews, while supporting QMS development across the organisation and ensuring audit readiness.

Qualifications

• Experience in Quality Assurance, Quality Systems or Quality Compliance within pharma.
• Strong knowledge of GMP, GDP and QMS.
• Experience managing deviations, investigations, root cause analysis and CAPAs.
• Experience coordinating Change Controls through to closure.
• Experience with supplier/vendor qualification and quality oversight.

Responsibilities

• Review third party GxP documentation to support batch disposition of respiratory products.
• Manage and review product complaints.
• Coordinate change control system per SOPs and close open items.
• Manage PMSI and deviation systems, raise records in TrackWise, assist investigations and ensure CAPAs are implemented.
• Ensure QTAs are in place with suppliers/service providers as appropriate.
• Manage product returns per GDP guidelines.
• Coordinate approval of new vendors and customers per GDP guidelines.
• Carry out annual Bona Fide checks on suppliers and customers.
• Maintain and update the department’s training and Learning Management systems.
• Support self-inspection and development of QMS at EU region.

Skills

QA experience

GMP/GDP knowledge

TrackWise experience

Deviation investigations

Education

Degree in scientific/pharmaceutical discipline

Tools

TrackWise

Job description

McDermott Laboratories Limited

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.

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 Quality System Specialist role will make an impact:

• Review of third party GxP documentation to support batch disposition of respiratory products.

• Management and review of product complaints

• To manage and develop the change control system in accordance with the relevant SOPs and to coordinate the follow up and closure of all open items.

• To manage the Pre-Market Supply Incident (PMSI) and deviation systems, including, but not limited to, the raising of PMSI/deviation records in the Trackwise system, assisting in investigations to determine root causes and the review of third-party investigation reports to ensure that root causes are determined and CAPAs (where applicable) have been implemented.

• To ensure Quality Technical Agreements (QTAs) are in place with affiliate and third party suppliers/service providers as appropriate.

• To manage product returns as per current GDP guidelines.

• To manage and coordinate the approval of new vendors and customers as per GDP guidelines.

• To carry out annual Bona Fide checks on suppliers and customers as per GDP guidelines.

• Carry out annual reviews/assessments on vendors and service providers to ensure appropriate performance of third party suppliers/service providers.

• To maintain and coordinate the MAH systems (e.g. Product Lists, QTAs, PQRs).

• To carry out annual reviews of manufacturing/packaging/release PQRs as part of the company’s responsibilities as QP release site and Marketing Authorisation Holder.

• To maintain and update the department’s training and Learning Management systems.

• Coordinate the distribution of wholesale related SOPs to relevant non-QA staff through the Learning Management System.

• The administration and conducting of risk assessments.

• To maintain and develop the SOP system in relation to the update, logging and distribution of SOPs.

• To support the self-inspection system.

• Actively support the development and implementation of the Quality Management System at Mylan Regional EU.

• Provide weekly and/or monthly KPIs for relevant systems to management.

• Compliance with current Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Standard Operating Procedures (SOPs) to ensure an audit ready facility.

• To adhere to all company and legislative health, safety and environmental requirements.

• Any other duties as assigned by the Quality Systems Manager/Quality Director.

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:

• Degree in a scientific, pharmaceutical or related discipline.

• Experience working in a Quality Assurance, Quality Systems or Quality Compliance role within the pharmaceutical industry.

• Strong knowledge and practical experience of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Quality Management Systems (QMS).

• Experience managing deviations, investigations, root cause analysis and CAPAs.

• Experience managing and coordinating Change Controls through to timely closure.

• Experience reviewing GxP documentation and working with third-party manufacturing sites, suppliers or service providers.

• Experience using an electronic Quality Management System, ideally TrackWise.

• Experience with supplier/vendor qualification, quality oversight and performance management.

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 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.