QA Validation Engineer

Team Horizon currently has an exciting contract opening for a QA Validation Engineer to work on our client’s medical device manufacturing facility in Sligo. The purpose of this role is to coordinate the development and maintenance of the site validation program and ensure external regulatory, quality, and compliance requirements are met.
 
Why you should apply:

• Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.

 
What you will bedoing:

• Coordinating and participating in the validation and quality assurance of site equipment, utilities, processes and software in compliance with FDA, European cGMP and GAMP standards.


• Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with AbbVie policies, FDA, European cGMP and GAMP standards.


• Generation/maintenance/execution of the Site Validation Master Plan.


• Generation/maintenance/execution of Project Validation Plans and schedules.


• Generation of validation protocols and final reports to cGMP standards.


• Generation of validation investigations and implementation of corrective actions.


• Creation/Review/Approval of various quality documents and test data.


• Management of validation, exception event, and change control processes.


• Maintenance and tracking of validation equipment, if applicable.


• Completing all required training before executing a task.


• Documenting all activities in line with cGMP requirements.


• Updating of validation procedures, job instructions and batch documentation to reflect current best practices.


• Performing cross training within the team and training of new team members.


• Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.


• Coordinating activities to maximize the effectiveness of all of the team members.


• Maintaining the overall cGMP compliance of the production areas.


• Communicating with peers and management regarding activities in the area, including elevation of events or concerns.

 
What you need to apply:

• Qualification and/or degree in engineering or scientific discipline.


• 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations.


• 3 years plus of knowledge of cGMP and regulatory requirements relating to the


• medical device industry.      


• Strong communication (written and oral), presentation and troubleshooting skills required


• Effective interpersonal and organizational skills.


• Ability to work well both independently and in a team environment.


• Capable of prioritizing work and multitasking.


• This position is crucial in identifying systems and processes requiring validation/quality assurance support and ensuring that those activities are documented, actioned, and resolved in a timely fashion. 


• Good communication and motivation ability is required.