QA Validation Engineer
- Connacht
- Contract
- Full-time
- 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.
- 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.
- 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.