Overview
Team Horizon is seeking a QA Validation Engineer on an initial 12-month contract for a Medical Device manufacturer in the Connaught region.
Why you should apply
You have experience in Quality / Validation engineering, enjoy a new challenge and have experience working on a range of projects.
You enjoy working with a diverse team on interseting projects, and want to work with a globally recognised manufacturing site.
Attractive rate on offer with potential for career development.
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 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
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.
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