The QA Senior Specialist will play a key role in the implementation and improvement of the local Quality Management System.  The QA Senior Specialist will provide hands on and Quality on the Shop Floor compliance support and oversight to activities of the Manufacturing facility and Laboratories, ensuring regulatory compliance and product quality requirements are always met

Responsibilities

• Provide QA support and oversight to the Irish operations team ensuring compliance with EU, Irish and FDA cGxP regulatory requirements, QMS and any other applicable regulations/standards Include 8-12 main activities
• QA review and approval of quality documentation generated in Irish operations e.g., including but not limited to Deviations, CAPAs, change controls, logbooks, SOPs, risk assessments, OOO/OOT, temperature logs, etc).
• Support a “Quality on the Shop Floor” culture through facility walk rounds to maintain a high level of compliance and QA oversight by working closely together with operations ensuring proactive approach to identify potential issues and minimise impact.
• 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 (plan, execute, follow up) self-inspections in a timely manner as per plan
• Perform external audits of key suppliers and service providers where required.
• Provide QA review for the eQMS system documents
• Aid in the management and proactively initiate and support continuous improvement of the Quality Management System.
• Deliver GxP compliance training to operational areas
• Ensure own work complies with GMP, Data integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g., SOP’s, BMR’s, Protocols, Guidance’s etc.

• 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
• Experience working in a GxP environment including a minimum 5 years’ experience in Compliance and Quality Assurance