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Quality Validation Engineer

Req ID: J2274116

  • Ubicación
    Waterford, Irlanda, Waterford, Ireland
  • Categoría Grupo de Calidad
  • Publicado martes, 25 de mayo de 2021
  • Tipo Tiempo completo

Descripción del Trabajo

SUMMARY
Generate applicable documentation to Automated Equipment Validation of Quality Management System.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

  • Generate applicable documentation to Automated Equipment Validation of Quality Management System.
  • Write the necessary validation protocols, & amendments of the Quality Management System ensuring compliance with the latest FDA directives / requirements within the Medical Device Sector.
  • Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company.
  • Development of validation projects.
  • Support the implementation of Company Policies and GMP.
  • Support all company safety and quality programs and initiatives.
  • Experience in working with Automation Vendors.
  • Ensure ongoing compliance with GMP in all practices, recording of events and processes.
  • Ensure compliance with all learnings from all GMP training events.
  • Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.


MINIMUM REQUIREMENTS

  • Degree in Engineering/Science discipline.
  • 2 to 4 years’ experience in a Validation Quality Engineering role.
  • Strong working knowledge of Validation Process. Experience in method validation and process characterization an advantage.

Skills/Knowledge

  • Strong working knowledge in the application of quality engineering tools and techniques with key emphasis on GAMP5 and Master Validation Planning.
  • Excellent organisation, communication, computer, & presentation skills.
  • Excellent initiative, decision-making and be able to work in a core team environment attaining resolutions.
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