Job Description:Yacht Life Sciences has a vacancy for a GMP and Documentation Specialist at Janssen Vaccines & Prevention in Leiden. The GMP and Documentation specialist within the Janssen Pilot Facility is the first point of contact within the production teams for questions related to cGMP (training, inspections, audits and documentation). In different team settings, you will work on the maintenance and improvement of the available cGMP systems.The GMP and Documentation specialist has a detailed understanding of cGMP and GMP documentation systems, such as Veeva truVault. You are an expert in handling non-conformances and follow-up. With process excellence/lean experience, you are able to identify and lead compliance improvement projects.As GMP and Documentation specialist, you will be responsible for:First departmental contact for questions about cGMP systemsInitiating and handling of compliance records (Change Control, non-conformances and CAPA records) including root cause analysisSupporting/leading in keeping process documentation up-to-dateCoordinating training system within the departmentSystem ownership of general production processes like gowning, routing and flow, segregationLeading role in the inspection readiness of the department, execution of inspections and follow upWorking accurately and detecting opportunities for improvement with proper follow up, both on compliance work processes as well as personal developmentArbeidsvoorwaardenTerms of employment:We offer a challenging secondment position for 1 year, which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. We will offer a competitive benefit package in line with the seniority of the position (salary between 3200 and 4200 euro gross per 4 week period). You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and to become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers, you will be able to follow courses and training via our Yacht Academy in order to keep your knowledge and skills up-to-date, i.e. boosting your career through personal and scientific growth.