Quality Systems Specialist: GMP/GDP & Change Control

Viatris

Dublin

Híbrido

EUR 60.000 - 90.000

Jornada completa

14 días+

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Ventajas ofrecidas por este puesto de trabajo

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Descripción de la vacante

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

Formación

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.

Responsabilidades

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.