QA Senior Specialist

QA Senior Specialist We are actively seeking to recruit a QA Senior Specialist to become a key member of the Quality team within a Dublin based Biotech Multinational. The successful candidate will deal primarily with QA vendor oversight activities including the review of commercial bulk and finished drug products, deviation, complaint, and change control record management. Responsibilities: • Manage contractor quality assurance activities to ensure product is manufactured, packaged, tested, released, and distributed in compliance with all regulatory and corporate requirements. • Leading discussions with the contractor on quality related topics. • Recommending quality related improvements to the contractor • Overseeing completion of contractor quality related activities, such as process, method and procedural improvements, quality investigations, corrective and preventive actions, etc. • Review batch records, both master production/packaging records and executed batch records ensuring compliance with GMP and registration requirements. • Manage change control requests. This includes, as necessary: • Process product complaints. • Review, edit, negotiate improvements to, and approve contractor documentation, • Lead review of Annual Product Quality Review reports, as necessary. Edit, and negotiate improvements to contractor supplied Annual Product Quality Review reports. • Draft or review, negotiate with contractors, and recommend approval for Quality Agreements Required Qualification(s) and Desired Experience • BSc or equivalent in scientific discipline • At least 5 years of experience in Quality Assurance in a pharmaceutical company. • Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development • Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically FDA and/or EMA • Experience in interacting with external manufacturers and supporting quality at external manufacturing sites