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
JD in Japanese follows. 英文の後に和文JDをご覧いただけます。 Introduction Our Mission Building trust for a seamless society. We challenge ourselves daily to achieve this mission. Merpays business started as a payment service, but that was just our first step
At Accelleron, we go further. Building on the heritage of more than 100 years as ABB Turbocharging, you will join a team of true experts in an exciting international environment that share a commitment to excel,
Job Description Shift Timing: 8 AM to 4:30 PM IST About the team: Our dedicated team provides round-the-clock technical support for our firm. We assist end users with a range of issues, from printer and computer
Return Flight-Supplier Quality Specialist - Nagoya, Japan Company: Boeing Japan Kabushiki Kaisha Job ID: 00000423765 Date Posted: 2024-06-11 Location: JPN - Nagoya, Japan Job Description Qualifications: (Japanese Follows) Boeing Commercial Airplanes Supplier Quality team is seeking a
Job Description As Location Support Specialist, you will handle a wide range of tasks involving hands-on support for end users. The role can be seen as Support Services’ pro-longed arm on site to provide technical assistance and
Job Title: Client Care Specialist Location: West Sahara What youll do: As a Client Care Specialist you will focus on displaying a high level of client service, and providing a professional, prompt, and accurate banking experience and exemplify
We are looking for a Editorial Support Specialist to join us in Reuters News & Media Technology. The role serves as a specialist in Reuters Special Technology Services (STS) team and merges end user support, system support work with
Job Title: Specialist, Sales Trainer Job Description The Sales Trainer facilitates and delivers targeted, focused training to teach and strengthen client-specific knowledge and skills, including sales processes and systems. The Sales Trainer collaborates with internal and/or external stakeholders to
At Dow, we believe in putting people first and we’re passionate about delivering integrity, respect and safety to our customers, our employees and the planet. Our people are at the heart of our solutions. They reflect
Woven by Toyota is the mobility technology subsidiary of Toyota Motor Corporation. Our mission is to deliver safe, intelligent, human-centered mobility for all. Through our Arene mobility software platform, safety-first automated driving technology and Toyota Woven
About this role Alternative Specialists Team (AST) helps BlackRock’s clients gain access to the investment teams, resources and strategies within our alternatives strategies platform, and is tasked to deliver solutions for our clients. AST has deep knowledge of
Job Description About the team: Our dedicated team provides round-the-clock technical support for our firm. We assist end users with a range of issues, from printer and computer hardware problems to navigating various applications. Based in
Range Operations Specialist The Opportunity: As an expert in defense missions, your unique skill set inspires you to think bigger, push further, and ask questions others don’t. We need your extensive industry knowledge and advisory skills to help
Company Description 会社の説明 Intuitiveでは、果たすべき使命に向けて皆で団結して取り組みます。当社は、低侵襲治療は生活をより豊かにする治療であると考えています。独創性とインテリジェントなテクノロジーを通じて医師の潜在能力を広げ、制約なく治療できるようにします。 私たちは、ロボット支援手術におけるパイオニアであり市場リーダーとして、インクルーシブで多様性のあるチームの育成に努め、変化を生み出すことに尽力しています。25年以上にわたり、世界中の病院や医療チームと協力して、ヘルスケアのいくつかの最も困難な課題の解決を支援し、可能なことを前に進めてきました。 Intuitiveは、さまざまなバックグラウンドを持つ優秀な人材の努力によって成り立っています。優れたアイデアはどこからでも得られると信じ、私たちは、思考の多様性と相互の尊重に根差したインクルーシブな文化の醸成に努めます。また、包摂性(インクルージョン)を持ってチームメンバーを指導し、ありのままの自分で最高の仕事ができるよう力づけます。 変化を生み出すことを望む情熱的な人々が、当社の文化の原動力となっています。私たちのチームメンバーは、誠実さを重視し、高い学習能力と物事をやり遂げるエネルギーを持ち、当社が新しい考え方ができるよう多様な実体験をもたらします。私たちは、チームメンバーが引き続き当社の使命を遂行し、最大限の可能性を実現できるよう、積極的に投資して彼らの長期的な成長をサポートします。 医療従事者と患者さんのグローバルなコミュニティを目指して大きく躍進しようと尽力しているチームの一員になってください。一緒に、低侵襲治療の向上に取り組みましょう。 Job Description Primary Function of Positions Based in Tokyo, Japan, the position will be responsible for orchestrating all facets of supply chain, encompassing demand planning, import/export, warehouse operations,
Company Description The Regional Marketing Specialist (RMS) supports the Regional Marketing Manager (RMM) in building the local face of Red Bull in their field in the most relevant way and in line with the global and national
Who We Are At Kyndryl, we design, build, manage and modernize the mission-critical technology systems that the world depends on every day. So why work at Kyndryl? We are always moving forward – always pushing ourselves to
Job Description: Department Overview Rakuten Bank is a full-service on-line banking company. Over 15 million customers have accounts, the highest among online banking companies in Japan. Rakuten Bank provides more than full-service. We provide not only
Mission Sustainment Specialist The Opportunity: As an expert in defense missions, your unique skill set inspires you to think bigger, push further, and ask questions others don’t. We need your extensive industry knowledge and advisory skills to help
■ 職務内容 / Job Description ・As an ER specialist, responsible for conducting the following agenda: 1. Managing Employee Relations cases including Bulling and Harassment allegations ・When speak up is done by employees or receiving any employee relations