Quality Systems Engineer - South Dublin
Quality Systems Engineer - South Dublin. This position is being offered as a fixed-term contract of 24 months' duration. Job Purpose: Reporting to the Quality Systems Manager, duties will include implementing & maintaining the company’s Quality Management System in accordance with applicable standards and regulations. Responsibilities: Be a key driver of cGMP practices within Operations and Quality divisions. Act as a primary contact for other departments providing quality oversight to ensure compliance and promote quality improvements. Ensure adherence to internal and external regulatory requirements. Be an active member of the internal audit team and support external audits at the site. Maintain effective implementation of site processes including Change Management, Internal Audits and CAPA. Prepare and present data to management on quality system performance. Drive thorough investigation & root cause analysis of CAPA's and Internal Audit findings. Support their timely resolution and ensure appropriate actions are taken to prevent recurrence. Support process improvement activities. Provide a quality review on a range of documentation including procedures, specifications, investigations, GMP records and other Quality Management System documentation as required. Interested applicants should have: A primary degree in a Science/Engineering discipline. A minimum of 5 years' work experience in a Medical Devices Pharmaceutical regulated environment working within an established Quality System. Proven experience leading CAPA's and internal audits. Strong problem-solving ability. Experienced in technical writing and review with good attention to detail. Proven ability of working on own initiative and in a cross-functional team environment. Excellent interpersonal and communication skills. Ability to prepare and present data effectively.
79 days ago