Quality Assurance Specialist I

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.- As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.- Perform internal & external (vendors) audits to assure compliance with the relevant ICON procedures, applicable guidelines and regulations.- Assist with customer and vendor audits and management of findings identified within database from initiation to closure.- Assist with the development and maintenance of procedures and quality plans.- Develop SOPs and can manage SOP development.- Represent Quality Assurance on computer validation project teams.- Provide guidance related to computerized validation policies, procedures and practices within the company.- Be knowledgeable with all relevant ICON SOPs and gave a thorough knowledge of appropriate regulations and guidelines.- Assist in management of Customer complaints in databases from initiation to closure.- Develops audit records and reports and provides signed statements for inclusion in records and reports.- Review and approval of Systems Development Life Cycle (SDLC) documentation to assure regulatory compliance.- Management of internal audit findings in database from initiation to closure.- Creation of schedules such as internal audits, vendor audits, maintenance plan.- Assume additional QA responsibilities as directed by the QA Director or higher.- Keep the person to whom the QA Specialist reports to informed of any QA issues within the department that require attention.- Work within standardized procedures and practices to achieve objectives and meet quality standards and deadlines.- Perform structured work assignments under instruction, guidance and direction by othersG- Excellent computer, documentation and communication skills are required.Project Management and/or IT auditor certification is a plus.- High english level**Benefits of Working in ICON**:Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.