QA Validation Engineer

Team Horizon is seeking a QA Validation Engineer for a 12 Month contract on behalf of our client, a leading medical device manufacturer in the Connaught region.

Why you should apply:

• Opportunity to cooordinate the development and maintenance of the site validation program and ensure  external regulatory, quality, and compliance requirements are met


• Work with a diverse & talented team on exciting projects

What you will be doing:

• Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with company 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.