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 coordinate 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, and execution of the Site Validation Master Plan.
* Generation, maintenance, and 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, and 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.
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