Requirements: English
Company: ireland.xpatjobs.com
Region: Dublin Dublin City
Quality Assurance SpecialistActively recruiting for a QA Specialist to become a key member of the Quality Team within a Dublin based Biotech multinational.Duties/Responsibilities:• Compilation and review of batch release dossiers for Qualified Person certification of IMP to clinical trials.• Updates and maintains the site Manufacturing and Importation Authorisation (MIA) in accordance with regulatory requirements and maintains the Site Master File.• Generates and maintains Product Specification Files (PSF) for IMP.• Provides QA support and oversight of packaging and labelling operations for IMP.• Support the generation and ongoing maintenance of Quality Agreements.• Provides Quality Assurance support in the Use Date Extension process.• Provides Quality Assurance oversight and support (GMP/GDP guidance and training) for CSO Logistics (EMEA and Asia)• Supports in a timely manner, investigations of non-conformances and quality incidents as QA. Resolves and documents in the Quality Management System quality. Conducts appropriate follow-up, as required. Tracks deviation, investigations and CAPAs.• Generate and complete QA review of supplier/customer qualification documentation for the Responsible Person (RP). Ensure supplier/customer qualification and re-qualification is complete within required timelines.Skills/Qualifications:• A degree in science, engineering or related discipline is essential along with 3 years’ experience in a role within the biopharmaceutical/pharmaceutical industry• Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance• Required to work on his/her own initiative in addition to working as part of a team. The candidate must be able to work across a team matrix in order to meet accelerated timelines.• Excellent communication, presentation and critical thinking skills are essential.For more information and a full job spec contact Nicola on (phone number removed) or email your CV in the strictest confidence to (email address removed)