QA Executive Level III (6 Months Fixed Term Contract)
دوام كامل
في Viatris Inc.
في
Ireland
نُشرت يوم May 8, 2024
تفاصيل الوظيفة
QA Executive Level III (6 Months Fixed Term Contract) page is loaded
QA Executive Level III (6 Months Fixed Term Contract)
Solicitar locations Inverin, County Galway, Ireland time type Tiempo completo posted on Publicado hace 3 días job requisition id R5646158 Mylan Teoranta En VIATRIS, vemos la atención médica no como es, sino como debe 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 evolución. Viatris permite a las personas de todo el mundo vivir de manera más saludable en cada etapa de la vida. Lo hacemos a través de: Acceso : suministro de medicamentos confiables de alta calidad independientemente de la geografía o las circunstancias; Liderazgo : promover operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente; Asociación : aprovechando nuestra experiencia colectiva para conectar a las personas con productos y servicios. 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 The Quality Assurance Executive will be responsible for assisting with the management of specific elements of the Quality Management System. These elements include the site change control procedure, deviation handling procedure, customer complaints and incoming inspection. Every day, we rise to the challenge to make a difference and here’s how the Quality Assurance Executive Level III role will make an impact:- 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 Production Records, Validation Documents and Development Documentation, Quality Control Data as required)
- Support the Quality Manager in the definition and maintenance of the annual internal and external audit programs, Annual product reviews and Quality management reviews for Mylan.
- Manage and Maintain the site Vendor Management System
- 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
- 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 Mylan projects providing advice and guidance to operational teams with support and guidance from the Quality Manager.
- Create, maintain and deliver training in quality related topics to Mylan personnel Support the Quality Assurance team in preparation of monthly/quarterly/annual reports to be submitted to senior management and Mylan departments to ensure visibility of QMS requirements and performance including the compilation of quality metrics to facilitate monitoring and management of the Mylan Quality System
- Minimum of a Bachelor's degree (or equivalent) in a Science or engineering related discipline 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 of sterile manufacturing desirable but not essential.
- Experience of all quality system aspects including: Deviation management, CAPA, complaint handling, auditing, change management, supplier qualification, and batch release.
- Experience of TrackWise or similar electronic document management systems is highly desirable
- Excellent communication (oral & written) and presentation 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.)
- Excellent career progression opportunities
- Work-life balance initiatives
- Bonus scheme
- Health insurance
- Pension
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