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  • 3 weeks ago

jobs description

A Quality Assurance Specialist is required by Careerwise recruitment to work with our Clare based client.

THE ROLE:
• 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.

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.

Please call Michael O’Connor today for further information on 091-452410 or email [email protected]

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent
Clara County Offaly Ireland

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