Description
Our Medical Device client have a long term contract opportunity for an experienced Quality Validation Engineer.Working within a new facility based in the south of Ireland we are looking for an experienced Validation Engineer with 3-5 years Validation experience to work on new automated equipment.
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 ability to work in a core team environment, attaining resolutions.
• Performance and Results driven.