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Quality Validation Engineer

Job Title: Quality Validation Engineer
Contract Type: Permanent
Location: Waterford
Industry:
REF: 88338
Job Published: about 2 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 091730022

Quality Validation Engineer Waterford
Department: Quality
Reports To: Senior Quality Engineer

Education/Training/Experience
  • 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.

Responsibilities of Position
  • Strong working knowledge in the application of quality engineering tools and techniques with key emphasis on GAMP5 and Master Validation Planning.
  • Generate applicable documentation to Automated Equipment Validation of Quality Management System. Experience in CAPA, NCMR systems, control plans, FMEA's, DOE's is an advantage.
  • 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.
  • Experience in working with Automation Vendors.
  • Other duties as required.

Skills/Attributes
  • 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.

For further information on this Quality Validation role in Waterford please contact Bimi Felix on 091730022 / bimi@hero.ie
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