Quality System Specialist

1100 Mylan Pharmaceuticals Inc.; Dublin; Hybrid; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Pension

Career progression opportunities

Job summary

Viatris, McDermott Laboratories Limited, ofrece un puesto de QA en Dublín para profesionales con experiencia en GMP/GDP y sistemas QMS. Gestionarás documentos GxP, quejas y cambios de control, asegurando cumplimiento y trazabilidad.

Trabajarás con proveedores y sitios de fabricación externos, mantenerás TrackWise, realizarás investigaciones de causas y CAPAs, y aportarás KPIs para la dirección. Se requiere título científico y experiencia en QA farmacéutica; desarrollo profesional y entorno

Qualifications

• 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.

Responsibilities

• 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.

Skills

GMP/GDP knowledge

Quality Assurance

Root cause analysis

CAPA management

TrackWise

Change control

Documentation review

Education

BSc in science or related

Tools

TrackWise

Job description

McDermott Laboratories Limited Viatris es una empresa sanitaria global en una posición única para tender puentes a la tradicional brecha entre genéricos y marcas, combinando lo mejor de ambos para abordar de forma más holística las necesidades sanitarias a nivel global. Con la misión de empoderar a personas de todo el mundo para vivir más saludables en cada etapa de la vida, ofrecemos acceso a gran escala, suministrando actualmente medicamentos de alta calidad a aproximadamente 1.000 millones de pacientes en todo el mundo cada año y abarcando todos los momentos de la vida, desde el nacimiento hasta el final de la vida, desde condiciones agudas hasta enfermedades crónicas. Hemos sido incluidos en varias listas de premios que demuestran el impacto que estamos generando. 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

• 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

• 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

En Viatris, ofrecemos salarios competitivos, beneficios y un entorno inclusivo donde puede usar sus experiencias, perspectivas y habilidades para ayudar a generar un impacto en la vida de los demás. Viatris es una compañía global del cuidado de la salud creada en 2020 a través de la combinación de Mylan y Upjohn, una división legada de Pfizer. Al integrar las fortalezas de estas dos compañías, incluida nuestra fuerza laboral global de aprox. 45,000, nuestro objetivo es proporcionar acceso mejorado a medicamentos de calidad asequibles a pacientes de todo el mundo, independientemente de dónde vivan o de las circunstancias. Creemos en el cuidado de la salud como debe ser: empoderamos a las personas de todo el mundo para que vivan de manera más saludable en cada etapa de la vida. Debido a nuestra creencia firme de que un acceso mejorado permite una mejor salud, aprovechamos nuestra experiencia científica y de manufactura inmejorable, al igual que las capacidades comerciales comprobadas, para ofrecer a los pacientes medicamentos de calidad en el momento y en el lugar que los necesiten.