Qa Engineer

Life Sciences/ Biotech/ Biopharma Validation Specialist Responsibilities: Ensures validation is executed as per the validation plan and/or system change request, and accuracy and quality of data for Q&R fields is maintained in the application inventory management system. Quality Assurance supports, and at times guides, the Business Process Owner, Business Process Expert, and IT team members who are executing the validation activities. Promote high, positive engagement from stakeholders with the process and team. Actively share knowledge and help solve problems with systemic issues driving positive, compliant impact, coaching/mentoring teams as well as assisting in problem-solving for systemic issues. This role will have documented approval actions in multiple deliverables in the QMS application. Perform record reviews to give feedback to authors/application owners. Gather and report data to monitor the validation execution quality and metrics/KPIs. Qualifications A minimum of 5 years, with 7+ years of experience working in a disciplined regulated industry, including validation of computer systems and systems security and control, and in the application of automated technology, particularly 21 CFR, ISO 13485, and GAMP 5. Solid Analytical skills with demonstrated ability to troubleshoot complex process/system issues. Understanding of applicable international and national laws, regulations and standards: FDA (CSV & CSA), ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485/EU MDR and EU Annex 11. Understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections.• Knowledge and experience in key QMS disciplines (e.g. production and process quality control, design quality control, product risk management, post market surveillance quality control as well as general QMS management) is preferred. High attention to detail. Strong organizational, writing/technical writing, (including clear logic and quality & regulatory compliance documentation approaches, good documentation practices), verbal, and interpersonal skills.