Quality Assurance Senior Specialist (Hybrid role)

Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. This role requires a strong focus on QA leadership in the design, installation, and qualification of facility, equipment, utility, and process systems, with particular emphasis on Validation Oversight. Key Responsibilities : Provide QA leadership during facility design, and layout Provide overall quality direction for processes and procedures associated with project Lead QA review and approval of URS, DS, QRAEs, and IQ / OQ / PQ protocols and reports. Act as the Quality point of contact and decision-maker during validation execution activities, ensuring all activities comply with regulatory and company standards. Ensure Computerised System Validation (CSV) meets regulatory and data integrity standards. Ensure validation documentation is robust, traceable, and inspection-ready. Drive risk assessments and mitigation strategies for new equipment and processes. Provide QA oversight for Change Controls, CAPAs, and Deviation Investigations. Ensure all activities align with Amgens safety standards, SOPs, and regulatory expectations. Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations. Education and Experience : University degree in a Science or Engineering-related discipline. Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry. Proven expertise in facility startup and Quality Oversight of Validation activities. Experience with change control, non-conformance resolution, and CAPA implementation. Excellent organizational, communication, and collaboration skills. Ability to work independently with minimal supervision and operate effectively across functional boundaries. Familiarity with Quality by Design (QbD). Proficiency in statistical analysis tools (e.g., Minitab, JMP) is a plus. If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.