Senior Design Assurance Engineer

Support the application of Design Controls in Product Development and Sustaining Changes ensuring that all changes are compliant to associated Pharmaceutical Regulations and Methods. Familiarity with requirements and procedures that govern the Pharmaceutical Industry including Eudralex Volume 4, GMP Guidelines", FDA 21 CFR 210, 211; GxP plus ICH Q8, 9 & 10. Manage and resolve product issues related to manufacturing, quality, or field performance. Support change control and risk management processes and generate documentation in alignment with quality system requirements Development and lead the execution of stability plan, protocols and reports for drug products through the life cycle of the product Coordinate and contribute with analytical test laboratories and teams for product investigations, OOS, OOT and significant change events Provides Quality support in the resolution of complaints investigation, CAPAs, NCMRs, Deviations, Root Cause Analysis and regulatory requirement changes. Summarise clear, concise conclusions and makes appropriate decisions from test data using excellent analytical and problem-solving abilities Uses knowledge of Statistical Analysis and Lean principles to investigate and solve problems and improve quality. Acts as SME in notified body audits and regulatory compliance for areas of expertise. Work with supply chain, incoming materials and packaging/labelling to ensure product is supplied to stringent quality levels. Interfaces with R&D, Regulatory Affairs, Operations, Validations, Clinical, Medical Safety and Pharmacovigilance providing technical input. NFQ Level 8 qualification in a STEM discipline Familiar with Minitab and data Analysis Minimum of 5+ years' experience in the Pharmaceutical Industry Good technical capabilities, communication skills, teamwork abilities and initiative. Proven ability to work well both as part of a team but also able to work on own with minimum supervision. Experience leading/supporting multiple complex projects and assignments.