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:
* Coordinate, direct, and actively participate in the validation and quality assurance of site equipment, utilities, processes, and software in compliance with company policies, FDA, European cGMP, and GAMP standards.
* Generate, maintain, and execute the Site Validation Master Plan.
* Develop and implement Project Validation Plans and schedules.
* Create validation protocols and final reports to cGMP standards.
* Conduct validation investigations and implement corrective actions.
* Create, review, and approve various quality documents and test data.
* Manage validation, exception events, and change control processes.
* Maintain and track validation equipment, if applicable.
* Complete all required training before executing tasks.
* Document all activities in line with cGMP requirements.
* Update validation procedures, job instructions, and batch documentation to reflect current best practices.
* Perform cross-training within the team and train new team members.
* Participate in continuous improvement programs to enhance manufacturing, quality, safety, and training systems.
* Coordinate activities to maximize team effectiveness.
* Maintain overall cGMP compliance of production areas.
* Communicate with peers and management regarding activities, including escalation of events or concerns.
What you need to apply:
* Qualification and/or degree in engineering or a scientific discipline.
* At least 3 years of validation/quality experience in medical device plastics processing, moulding, or assembly operations.
* At least 3 years of knowledge of cGMP and regulatory requirements related to the medical device industry.
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