Social network you want to login/join with:
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.
#J-18808-Ljbffr