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Validation Engineer

Req ID: J2283383

  • Ubicación
    Waterford, Irlanda, Waterford, Ireland
  • Categoría Grupo de Calidad
  • Publicado jueves, 2 de septiembre de 2021
  • Tipo Tiempo completo
  • Tipo de Empleo Trabajador Eventual

Descripción del Trabajo

Contractor - 12 months

Position Summary:

  • Generate and execute applicable validation documentation for Moulding, Assembly, Test Equipment, Computerized Systems, Facilities and Supplier Validation within the Quality Management System.

Key Responsibilities and End Results: (Essential responsibilities include but are not limited to the following):

  • 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 Regulatory Agencies (HPRA, FDA) directives / requirements within the Medical Device and Pharma 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 and Moulding Vendors.
  • Ensure ongoing compliance with GMP in all practices, recording of events and processes.
  • Ensure compliance with all learnings from all GMP training events.
  • Perform and generate Risk Assessment documents for regulated processes within the scope of the QMS.
  • Knowledge and use of LEAN 6 sigma tools for problem solution.
  • 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.

3.0  Job Specifications :   The minimum education and experience required to perform this job competently.

  • Degree in Engineering/Science discipline.
  • 3 to 5 years’ experience in a Validation Quality Engineering role.
  • Strong working knowledge of Validation Process. Experience in method validation and process characterization an advantage.

Skills/Attributes:

  • Strong working knowledge in the application of quality engineering tools and techniques with key emphasis on Eudralex, ISO13485, GAMP5 and FDA Pharma and medical devices regulations.
  • Excellent organisation, communication, computer, & presentation skills.
  • Excellent initiative, decision-making and be able to work in a core team environment attaining resolutions.
  • Performance and Results driven.

4.0  Organization Linkages:   List the titles of individuals and organizations with which this position has the most frequent and significant contact.  Briefly describe the nature of those contacts.

  • Reports to Senior Quality Engineer.
  • Department Managers and Employees.
  • Operations.

Validation of Assembly and Moulding Processes

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