Overview
QAV Engineer - Ireland, Sligo - 12 Month Contract
Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a QAV Engineer to join their state-of-the-art pharmaceutical facility. They have invested $55 billion in research to discover and develop new medicines in the pursuit of scientific breakthroughs and changing people’s lives. They have 50,000 employees around the world and are continuing to grow.
Responsibilities
* 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 maximise 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.
Desirable Experience
* Qualification and/or degree in engineering or scientific discipline.
* Requires extensive validation/Quality experience in medical device plastics processing, moulding or assembly operations.
* Extensive knowledge of cGMP and regulatory requirements relating to the medical device industry.
* Strong communication (written and oral), presentation and troubleshooting skills required
* Effective interpersonal and organisational skills.
* Ability to work well both independently and in a team environment.
* Capable of prioritising work and multitasking.
If this role is of interest, please apply now!
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