QA Executive Level III (Packaging) page is loaded
QA Executive Level III (Packaging)
Solicitar locations Casla, County Galway, Ireland time type Tiempo completo posted on Publicado hace 26 días job requisition id R5659483 Mylan Teoranta
En VIATRIS, vemos la atención médica no como es, sino como debería de ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en constante evolución.
Viatris ayuda a las personas de todo el mundo a vivir de manera más saludable en cada etapa de la vida.
Lo hacemos a través de:
Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias;
Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente;
Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.
Every day, we rise to the challenge to make a difference and here’s how the QA Executive Level III role will make an impact:
Key responsibilities for this role include:
* Lead specific Quality management system elements such as GMP investigations, Change Control, CAPA and Risk Assessment and Customer Quality Complaints/Medical Device Vigilance systems.
* Support the Qualified person(s) to lead and perform data review audits (Batch Packaging Records, Warehouse Documentation, Engineering Documentation, Validation Documents and Development Documentation)
* Support the Quality Manager in the definition and maintenance of the annual internal audit programs, and Quality management reviews for Viatris.
* Support the quality organisation to meet the needs of the growing business; using technical expertise, skills knowledge and experience as required to resolve problems and share knowledge
* Support the Quality Manager with introduction and qualification of new equipment and new products.
* Review and approve suppliers / service providers including supporting with audits of critical suppliers where required
* Support the Quality Manager with hosting external audits and regulatory inspections
* May act as principal project quality lead for new and existing Viatris projects providing advice and guidance to operational teams with support and guidance from the Quality Manager.
* Support the Artwork team in implementation, update and obsoletion of artworks, as required.
* Create, maintain and deliver training in quality related topics to Viatris personnel. Support the Quality Assurance team in preparation of monthly/quarterly/annual reports to be submitted to senior management and Viatris departments to ensure visibility of QMS requirements and performance including the compilation of quality metrics to facilitate monitoring and management of the Viatris Quality System
* Operational support on shop floor in relation to packaging line approvals and clearances, serialization and change management activities.
The minimum qualifications for this role are:
* Minimum of a Bachelor's degree (or equivalent) in a Science related discipline and 2 and at least 5years relevant experience within a relevant sector (i.e pharmaceutical/medical device industry) with a minimum of 3 years’ experience within a Quality Assurance role.
* Experience in a Quality Assurance role in a Pharmaceutical/Medical Device Packaging Department is desirable but not essential
* Experience of working with various IT systems and software packages with strong working knowledge of Microsoft Office (Word, Excel, Powerpoint etc.)
* Knowledge and or experience of all quality system aspects including: Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification, batch release.
* Excellent communication (oral & written) and interpersonal skills.
* Ability to handle multiple tasks in a fast paced environment with strong organisational and time management skills.
* Experience of working with various IT systems and software packages with strong working knowledge of Microsoft Office (word, Excel, powerpoint etc.)
* Competent in the use of Microsoft Excel/Word
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 li
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.
#J-18808-Ljbffr