Work Schedule Other Environmental Conditions Office Job Description 職務内容: 医療機器、体外診断用医薬品、動物用医薬品、研究用試薬(消耗品、機器含む)に係る薬事対応業務 ・製造販売業の維持・管理(更新申請手続き等、3役会議事務局運営など) ・販売店が保有する高度医療機器販売業・貸与業、医薬品販売業、動物用医薬品卸売販売業の管理 ・QMS適合性調査申請(承認前調査/定期調査) ・外国製造業者認定・登録の維持・管理 ・QMS内部監査対応(被監査部門への監査の実施、報告書作成保管等 1回/年) ・GVP対応(情報収集、当局報告、記録書作成保管等) ・薬事トレーニングの実施管理(年間計画の立案、トレーニング資料作成、e-learning等での実施、記録書作成保管等) ・プロモーションマテリアルレビューの管理 ・海外拠点及び顧客からの問合せ対応 必要とされる資格・経験 ・医薬品、医療機器、又は体外診断用医薬品分野におけるRAQAでの業務経験(1年以上) ・薬事規制(特に安全管理業務)に関する知識 ・当局対応経験 ・海外とコミュニケーションを行う英語力(メール対応) ・基本的なPCスキル(Word、Excel(表計算・グラフ作成)、PowerPoint) 歓迎される資格・経験 ・規制当局又は認証登録機関によるQMS適合性調査・ISO13485調査対応経験 ・安全性に関わる業務経験 ・ドキュメント管理システムの使用経験 ・製造販売業の三役の経験 Thermo Fisher Scientific Inc. is
Job Description As a quality assurance engineer for chemical substances contained in products, you will be involved in the following tasks. Depending on your experience and skills, we will consider the work you will be responsible for
Are you looking To make meaningful changes at the fastest-growing tech company in Japan? For a fair, highly flexible, inclusive working environment where anyone, regardless of their background, can make an impact? To build the next
Company Description Publicis Groupe is not just a company you work for; it’s a platform for you to take your talent to the world. If you want to help change the world, ideas alone are not
ABOUT US We are Alter Domus. Meaning “The Other House” in Latin, Alter Domus is proud to be home to 85% of the top 30 asset managers in the alternatives industry, and more than 5,000 professionals
We are a leading financial services provider committed to making decisions easier and lives better for our customers and colleagues around the world. From our environmental initiatives to our community investments, we lead with values throughout
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our
Our vision is to transform how the world uses information to enrich life for all. Micron Technology is a world leader in innovating memory and storage solutions that accelerate the transformation of information into intelligence, inspiring
The Logistics Coordinator will plan, operate and manage the supply-chain network, understanding inventory, freight transportation modes and routes. In addition, understand inventory management and its process in the warehouse, including confirmation of daily inventory, month-end inventory,
* Engineering manager at Fintech Company * Flexible working environment and housing allowance is available Client Details * Global fintech Company with overseas branches. * Their service has more than 15M users. Description * Cross-cutting decisions (technical
* Global team with flexible working environment * Fintech startup with modern tech-stack and offices in overseas Client Details Fintech Start-up offering a cloud-based property management platform. Global team with the members from over 10 countries Description
Lead in GQP QA operational activities for the business for company products. Ensure effective compliance, continuous improvement activities, and overall quality processes. Client Details * Global Pharmaceutical company specializing in generics, biosimiilars, APIs, and new products
Take lead in CMC RA activities for the business in regulatory strategy/maintenance to obtain and maintain regulatory approval. Contribute and support the CMC RA organization both domestically and overseas members Client Details * Global Pharmaceutical company specializing
As an HRBP, you will be responsible for one of the companys cor business units. You will be flexibly devising human resources strategies while overseeing aspects such as personnel systems, talent development, performance management, succession planning
* Manage logistics activities for ongoing windfarm construction projects * Collaborate with logistics vendors to ensure smooth import/export process of heavy machinery and spare parts items Client Details Our client is a multinational company that is
* Lead the end-to-end supply chain process from planning, purchasing, logistics, and customer service * Manage a team of staff and drive continuous improvement activities Client Details Our client is a multinational chemical company that manufactures
A world-renowned media and entertainment company is looking for a Facilities Technical Infrastructure Senior Specialist/Assistant Manager. The position is based in Osaka and requires on-site work with flexible schedules. FULL relocation support is available. About The
Responsible for account management in Automotive Tier1 and Illumination fixture manufactures. Client Details A lighting company that develops, manufactures, and distributes LEDs, light bulbs, and related products for automotive lighting, general lighting, and speciality lighting. Description
Selling companys memory products through distributors. Client Details International company manufacturers various ICs including serial flash, dynamic memory, micro-controllers, and super I/O chips. Description * Build good relationships with customers * Collect market information and grab
Are you looking for an opportunity where you can leverage your accounting and admin skills with a leading global supplier of machinery and services to the packaging and label industries? Amazing opportunity with great benefits that