Job Description
An amazing opportunity has arisen for a Quality Systems Specialist to join our team at our Dunboyne facility. The successful candidate will be responsible for maintenance and continuous improvement of the Quality Management System (QMS). The Quality Systems Specialist will play a crucial role in ensuring compliance with regulatory requirements and driving continuous improvement in our quality systems.
What you will do: Provide quality support to the site, including training and guidance on the interpretation and implementation of our Guidelines / Policies and regulatory requirements.The main areas of expertise are, but not limited to, specific tasks and roles such as: supplier quality management, quality agreements, new product introduction, deviation management, change control management, quality systems management, document / SOP management, master data management, complaint management.Ensure the health & well-being of the Quality Management system at the site to ensure timely actions are taken to meet compliance & production needs.Serve as support for metrics management for site quality systems.Support Regulatory and Compliance Inspections at the site, as required.Comply with our Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.What skills you will need: Minimum degree or post-graduate qualification (Science/ Pharmacy/ Engineering).At least 3 years' experience in the pharmaceutical industry (preferably experience in Biologics)Understanding and practical application of GMP standards and regulationsWorking knowledge of QMS regulations and best practicesDesire to continuously learn, improve and develop.Excellent communication and interpersonal skills, with the ability to collaborate effectively at all levels of the organization and with external partners.Analytical problem-solving skillsEmployee Status: Regular
Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid
Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 11/23/2024
Requisition ID: R320931
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