QA Validation Engineer

Desired Skills: validation,quality assurance,moulding

The role

PE Global is currently recruiting for a QA Validation Engineer on behalf of a leading medical device company based in Sligo. This is an initial 12-month contract role.

Responsibilities

To coordinate the development and maintenance of the site validation program and ensure external regulatory, quality, and compliance requirements are met. Coordination, implementation and active participation in the site Validation Program and general Quality Assurance activities.

• 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.

Education and Experience

• 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.
• Strong communication (written and oral), presentation and troubleshooting skills required
• This position is crucial in identifying systems and processes requiring validation/quality assurance support and ensuring that those activities are documented, actioned, and resolved in a timely fashion.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***