QA Specialist (Clare / Limerick)

CareerWise Recruitment

Shannon

QA SPECIALIST required by CareerWise Recruitment for our Gene Therapy client at their start-up facility in Co. Clare. This is a permanent role. The QA SPECIALIST will provide support and oversight for the Irish manufacturing site during facility design, build and qualification for the manufacture and supply of clinical and commercial advanced therapies Medicinal products (Gene Therapy viral vectors). The QA SPECIALIST will also play a key role in the implementation of 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 met at all times. THE ROLE: * Provide QA support and oversight to the Irish operations team, ensuring compliance with EU, Irish and FDA cGxP regulatory requirements, MeiraGTx 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 a 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 Materials. * 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. * Ensure own training in undertaken in a timely and GMP compliant manner before the task is undertaken. * Ensure own KPl's, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines. Aid in maintaining QA Operations Team KPls. 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. * Positive attitude with demonstrated flexibility to adapt to the needs of the department/wider business, demonstrating good organisational and time management skills. * Can identify and escalate issues to line management to ensure workload is prioritised, and issues are highlighted to ensure business needs are met. * Experienced in performing internal and/or external audits. * Proficient in Microsoft Office and experience in database use and eQMS systems. * Experience in the management of Competent authority, Regulatory body inspections and audits. Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@careerwise.ie. 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.

174 days ago