Qa Validation Engineer

1 day ago

Sligo, Sligo, Ireland Team Horizon Full time

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.
Please note:
If you are not a passport holder of the country for the vacancy, you might need a work permit.
Check our blog for more information.
Bank or payment details should not be provided when applying.
All applications should be made via the 'Apply now' button.
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