QP / Qualified Person / Souseki (m/f/x) – Yokohama

Job description

GENERAL INFORMATION Become the wind beneath our wings in all pharmaceutical and drug-related issues. We are looking for a QP / Qualified Person / Souseki (m/f/x) Location: Yokohama Starting: at the next possible date YOUR PROFILE The Feathers in your caps: You’ve been successfully certified as a pharmacist in Japan. You’ve got 3+ years of experience related to quality control or post-marketing safety control of pharmaceutical products, or other similar work in Japan. You possess strong analytical thinking and problem-solving skills. You don’t get your feathers ruffled when it comes to taking on tasks that aren’t directly related to your position because your team needs your help. Your fluency in Japanese allows for a smooth communicate with the team. Basic knowledge of English is a plus. YOUR TASKS The tasks you’ll tackle with your wisdom: You perform the responsibility of a Qualified Person (QP) / Soukatsu Sekininsha according to Japanese regulation. You establish GQP and GVP in-house to be granted or maintain the manufacturing and selling licenses for Class 1 pharmaceuticals, Class 2 pharmaceuticals, quasi-pharmaceutical drugs, and possibly cosmetics. You monitor Japanese GxP status as well as manufacturing and testing of medicinal products – always with regard to the respective guidelines. With an eye for detail, you take care of market releases of batches before they’re placed on the market, maintenance of the ongoing release register, and annual preparation of PQRs. You handle the tasks of the responsible person for narcotics. You take care of the approval of qualification and validation measures. You carry out internal and external audits with vigilance. You act as a contact person for authorities and customers. You provide advice and support for colleagues as well as customers in all pharmaceutical and drug law related issues. NO MATTER IF EARLY BIRD OR NIGHT OWL: You are flexible in your working hours, your location, and your work itself. You will also have a big say in what exactly you and we are aiming for. But above all, we are interested in you as a person and focus on your specific talents. We are looking for that certain something – and will give it to you in return. Odd bird, crazy goose, or wise owl? We welcome birds of all feathers! Ready to spread your wings? Send us your application directly via our application form.