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 Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.
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
Operations Specialist The role involves managing trade lifecycle of daily trading activities of all portfolio managers trading Equity and Fixed Income products across APAC region, as well as leading projects and initiatives and providing control framework and
Company Description Renesas is one of the top global semiconductor companies in the world. We strive to develop a safer, healthier, greener, and smarter world, and our goal is to make every endpoint intelligent by offering
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
Are you ready to unleash your full potential? We’re looking for people who are passionate about payments to chart Worldpay’s path to being the largest and most-loved payments company in the world. About the team The
Cochlear is the global market leader in implant hearing solutions. Cochlears mission is to help people hear and be heard. Around the world, more people chose a Cochlear-branded hearing implant system than any other. A Cochlear Implant
Görev Tanımı The Position Individual contributor is accountable for ensuring all activities at the External Entity (EE) site associated with the manufacturing of Company products which includes quality oversight over manufacturing, testing, packaging, storage, and distribution
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
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
Seeking a Subject Matter Expert on regional Extended Workforce (EW) Operations via Vendor Management System (VMS). Key Responsibilities EW Request Lifecycle Management through VMS Intake of EW request from stakeholders: collaborate with CBM and GSP Country Focal
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 Summary -Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health
At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your
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
Supplier Quality Specialist - Nagoya, Japan Company: Boeing Japan Kabushiki Kaisha Job ID: 00000423311 Date Posted: 2024-05-06 Location: JPN - Nagoya, Japan Job Description Qualifications: (Japanese Follows) Boeing Commercial Airplanes Supplier Quality team is seeking a Supplier
DUTIES Responsible for coordinating the delivery of advanced services, post-sales activities, and verification support services. Manages multiple advanced and verification support services for the client. Responsibilities include troubleshooting, the overall planning, organizing, directing, controlling, and delivering
