Quality Assurance Specialist
The purpose of this role is to support the development and implementation of quality systems strategy and activities to achieve International Business Unit (IBU) goals and objectives. This includes acting as a quality consultant and leader in integrating quality requirements into business processes, implementing the quality plan, and ensuring consistency between global and local requirements.
This role will facilitate audits and inspections, manage audit and inspection responses, communicate inspection readiness requirements, and ensure completion of audit or inspection CAPA plans. Additionally, it involves partnering with business areas to strengthen and ensure appropriate quality controls are in place, sharing key learning to drive simplification, and collaborating with other quality groups as needed.
The ideal candidate will have a Bachelor's or Master's degree in a science or healthcare-related field, with three years of experience in quality and/or drug product safety/regulatory. They must be able to implement, interpret, and apply quality systems within a regulated work environment, demonstrate effective communication and problem-solving skills, and prioritize and handle multiple concurrent tasks.
This position requires a strong understanding of quality systems, including GMP, GCP, and GVP, as well as cognitive abilities such as problem-solving, verbal reasoning, attention to detail, critical thinking, and analytical competencies. The ability to work in a global environment and cultural sensitivity are also essential for success in this role.