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A Quality Assurance Specialist is required by Careerwise recruitment to work with our Clare based client.
Role of this position
* 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.
* Generate and prepare quality documents e.g., SOP's and controlled documents e.g., SOPs and Training Material.
* Ensure compliant and adequate systems are in place to monitor investigations, CAPAs, audits and Quality Review Boards.
* Support the preparation, execution and follow up on regulatory inspections.
* Perform external audits of key suppliers and service providers where required.
* Provide QA review for the eQMS system documents.
JOB REQUIREMENTS
* Experience working in a GxP environment including a minimum 5 years' experience in Compliance and Quality Assurance.
* 10 years of experience of 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.
* Experienced in performing internal and/or external audits.
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