We are looking for individuals who are committed to making life better for people around the world. Our primary responsibility is to manage data activities within our site, ensuring its integrity and compliance with enterprise initiatives. As a Site Data Leader, you will be responsible for leading the Site Data Lead Team, maintaining site data management metrics, and reporting status to the team. You will also provide direction on the operationalization of the data management action plan and partner with site leadership to ensure data integrity initiatives receive appropriate priority and resources. Additionally, you will implement defined data standards and usage guidelines, as well as data strategy actions to enable robust decision-making and drive productivity. This role requires a minimum of 3 years of experience in GMP or QMS operations, knowledge of domestic and international data integrity regulations, and understanding of IT system design and usage. Fluency in English (GSE: 42 or higher) and Japanese (native level) is required. The ideal candidate will have strong project management skills, the ability to work independently and in a team environment, and excellent communication skills. Salary is competitive and includes benefits such as housing allowance, commuting expenses, and performance-based bonuses.
-
Kobe Lilly Full timeWe're looking for people who are determined to make life better for people around the world. · Overall Job Purpose: · 西神製造所における医薬品/医療機器製造工程、製品試験に関する製品品質保証業務 · Job Responsibilities: · 新製品導入に伴うGMP対応、品質保証システムの構築、社内関係部門との調整(社内の国内、海外関連部門と協働し、GQP, GMPに基づく製造所としての品質基準、保証システムを構築) · 国内販売 ...
-
Kobe Lilly フルタイム人生を世界中で良くすることに決めた人が必要です。 · トレーニングおよび文書システムの維持および改善 · 文書管理システムの運用および管理 · 文書管理責任者(または文書管理担当者) · 文書および記録の保管および管理(GMP Library、GQP/QMS Archive) · GMP/QMS/GQP/GDPに基づく基本的な文書(GMP/QMS/GQP概要、手順書類)の維持 · 手順書類の制定およびメンテナンス、並びにこれらに関する他の部署へのサポート · 署名の管理 · トレーニングシステムの運用 · 教育訓練責任者(または教育訓練担当者) · 年間 ...