Ref No: AM17496
Validation/Quality Engineer - County Waterford.
Generate and execute applicable validation documentation for Moulding, Assembly, Test Equipment, Computerized Systems, Facilities and Supplier Validation within the Quality Management System.
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.
Interested applicants should have:
Degree in Engineering or Science discipline.
At least 5 years’ experience in a Validation Quality Engineering role.
Strong working knowledge of Validation Process. Experience in method validation and process characterisation an advantage.
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.