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A Quality Assurance Specialist is required by Careerwise recruitment to work with our Clare based client.
Role of this position
1. Provide QA support and oversight to the Irish operations team ensuring compliance with EU, Irish and FDA cGxP regulatory requirements, company QMS and any other applicable regulations/standards.
2. Generate and prepare quality documents, e.g., SOPs and controlled documents such as SOPs and Training Material.
3. Ensure compliant and adequate systems are in place to monitor investigations, CAPAs, audits, and Quality Review Boards.
4. Support the preparation, execution, and follow-up on regulatory inspections.
5. Perform external audits of key suppliers and service providers where required.
6. Provide QA review for the eQMS system documents.
Job Requirements
* Experience working in a GxP environment, including a minimum of 5 years' experience in Compliance and Quality Assurance.
* 10 years of experience working in a GMP regulated environment, biotechnology, or related manufacturing is preferred.
* Experience in the operation and improvement of all aspects of a local QMS, including investigations, change controls, and CAPAs.
* Experience in performing internal and/or external audits.
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