Our client is seeking a QA Validation Engineer to join their team at their Sligo Facility.
Responsibilities To coordinate the development and maintenance of the site validation program and ensure Abb Vie and external regulatory, quality, and compliance requirements are met.
Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities.
Coordination / direction and active participation in the validation and quality assurance.
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 c GMP 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 c GMP 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 Coordinating activities to maximize the effectiveness of all of the team members.
Maintaining the overall c GMP compliance of the production areas.
Communicating with peers and management regarding activities in the area Essential Requirements Qualification and/or degree in engineering or scientific discipline.
Technical/Business Knowledge -Job Skills/Experience Required 3 years plus validation/Quality experience in medical device plastics processing, moulding or assembly operations.
3 years plus of knowledge of c GMP 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.
For a confidential discussion and more information on the role, please contact Emma Daly Skills: moulding and assembly knowledge of automated lines validation