Validation Engineer - South Dublin. In this role you will be accountable for the following functional areas in the Quality department: Process, Facility, Software and Equipment Validations. Key Responsibilities: • Key Team member for the following functions within the Quality Department: o Process Validation. o Facility Validation. o Software Validation. o Equipment Validation. • Support and contribute to a Quality culture based upon risk management, process mastery, data-driven analytics and goal-oriented performance accountability. • Support the maintenance of an effective Quality Management System that complies with international standards and relevant regulatory requirements e.g., EU IVDD, HPRA, FDA, Health Canada, etc. • Understand new regulations and guidelines, and implement systems and procedures to incorporate these new regulations. • Establish, track and respond to leading and lagging Quality Key Performance Indicators (KPIs) for functional areas under responsibility. • Process ownership of Validation Systems. • Ensure clear and unambiguous requirements for validation activities. • Provide and support validation resources for cross-departmental projects; manage these resources within a defined project management framework. • Ensure that all validation protocols and reports meet the requirements of the Quality Management System. • Prepare, maintain and review Quality System documents relating to validation (IQ, OQ, PQ, URS etc. • Prepare and maintain Risk Assessments. • Support product and facility inspections. Qualifications / Experience Sought: • Primary degree qualification in a science, engineering or business discipline. • Minimum 2 years' experience in healthcare, medical device, in-vitro diagnostics or related industry. • Validation protocols and reports. • Project management of cross-functional teams. • Building and leading effective teams, and highly motivated individuals. • Excellent verbal and written communication skills. • Technical writing expertise in validation processes, protocols and reports. • In-depth knowledge of validation requirements. • Ability to successfully implement change. • Strong analytical/problem-solving skills. • Ability to collaborate with and influence groups in a positive, team based environment. This job originally appeared on RecruitIreland.com.
100 days ago