職務の目的および主な業務内容 Quality Management Systemの中で、主に以下の業務を担う。 ・文書管理 (工場内の標準書及びGxP文書の管理) ・Regulatory関連（当局とのコミュニケーション、変更案件の薬事影響評価、本社CMCとの連携、当局監査のマネジメント） ・自己点検、課内点検のマネジメント ・ワクチンの国家検定 ・GSK StandardであるQuality Management System（GSKのstandard）のサイトへの導入 ・GxPにかかわる教育管理 上記の業務を実施しながら、生産現場を含むQA以外の部、Functionとも連携をとり、改善活動を実施していく。 上記業務のほかに、コンプライアンス課では、品質の取り決め書の作成、製品及び原料の品質QC実験用の規格基準設定、製品に使用される資材の規格設定及び取り決め書（品質契約書）作成変更管理、サプライヤーコントロール などを主とするGroupがあり、２つのGroupにてお互い協力しながら、業務を遂行している。よって、QMSの多岐にわたる業務にかかわることができ、将来のQA内外へのキャリアプランやDevelopmentにプラスとなる業務を担うことができる。業務の内容によっては、グローバルチームや他のサイトとのCommunicationをとることがある。 必要な条件 スキル ・GMPの知識 QMS概論の知識 ・英語（技術文書の読解、メールでのコミュニケーション、電話会議参加） ・PC skill（Word, Excel, PowerPoint） ・基礎的な問題解決能力 ・工場内外において相互協力、協調して作業を行う能力（コミュニケーション能力） 経験 ・製造業での品質業務経験 ・当局監査対応 学位/資格 ・薬学、化学、工学等の理系分野の学士以上 望ましい条件 スキル ・医薬品の生産工程、関連する原資材に関する必要とされる知識 ・安全衛生の理解 ・SAPの知識 ・分析機器、統計の知識 ・局法の知識（JP
We support peace and prosperity by building connections, understanding and trust between people in the UK and countries worldwide. We work directly with individuals to help them gain the skills, confidence and connections to transform their
Interior Composite Materials & Process Engineer - Nagoya, Japan Company: Boeing Japan Kabushiki Kaisha Job ID: 00000426362 Date Posted: 2024-06-11 Location: JPN - Nagoya, Japan Job Description Qualifications: (Japanese Follows) Boeing Research & Technology (BR&T) defines,
The Oracle Cloud Infrastructure (OCI) Dedicated Cloud Product Solutions Product Support Engineering team is looking for an experienced and motivated Senior Technical Program Manager (TPM) to spearhead engagement, technical advisement, and relationship management with OCI’s Dedicated
Field Service Engineer, Japan As a Field Service Engineer you will perform assembly, disassembly, and repair work on analytical laboratory instruments and equipment and effectively and safely utilise test equipment, hand tools and power tools as
Job Description Govern the execution of Manufacturing Engineering activities in the External Supply Chain to assure the development, maintenance and continuous improvement of manufacturing processes and/or methods of manufacture which are capable of meeting and continuing
Background Diversity, Equity and Inclusion are core principles at UNDP: we value diversity as an expression of the multiplicity of nations and cultures where we operate, we foster inclusion as a way of ensuring all personnel
The candidate should have electricity , instrument and DCS engineering capability for project execution RESPONSIBILITIES Contribute to the analysis of information, the specification of the methods, process steps, and the plant, machinery and equipment required to
Company Description Headquartered in Bethesda, Maryland, ISN Corporation is a nationwide provider of specialized professional services to Federal government agencies. ISNs portfolio includes work with over 100 Federal agencies. ISN Corporation has been awarded a place
職務の目的および主な業務内容 Job Purpose & Key Responsibilities VEO Expertは、担当品目のValue Evidence Planの作成および実行に責任を持ちます。Evidence needsおよびGapを評価し、製品価値を高めるための最も適切な試験計画を組織横断チームにて立案し、提案していきます。 VEO Expert contributes to develop Japan Value Evidence Plan (J-VEP) of the assigned products. VEO Expert plan, implement and deliver high quality, scientifically robust research projects
Tulip, the Frontline Operations Platform, is empowering the world’s leading manufacturers to improve the productivity of their teams, the quality of their output, and the efficiency of their operations. With Tulip’s no-code platform, manufacturers can empower those
Tulip, the Frontline Operations Platform, is empowering the world’s leading manufacturers to improve the productivity of their teams, the quality of their output, and the efficiency of their operations. With Tulip’s no-code platform, manufacturers can empower those
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
Why Nasdaq When you work at Nasdaq, you’re working for more open and transparent markets so that more people can access opportunities. Connections can be made, jobs can be created, and communities can thrive. We want
Job Description: ■Mission Supporting the conservation of our corporate value and sustainable growth of our business that provides Rakuten Edy, Rakuten Cash, Rakuten Pay, Rakuten Point Card, etc. By grasping risks across the organization and actively
Job Description Summary The Commercial Controller role is responsible for commercial accounting in the region of GEHC. This role drives activities supporting the region’s overall and commercial activities. The position supports various functions, including the region
JOB SUMMARY Manages all engineering/maintenance operations, including maintaining the building, grounds and physical plant with particular attention towards safety, security and asset protection. Accountable for managing the budget, capital expenditure projects, preventative maintenance and energy conservation.
Technical Support Engineer – Optical Telecoms & DWDM Melbourne, Australia Home & Office Hybrid Act as DWDM system engineer to test already designed and build up DWDM rings in a test environment with the following activities: Prepare
Return Flight - Interior Composite Materials & Process Engineer - Nagoya, Japan Company: Boeing Japan Kabushiki Kaisha Job ID: 00000426776 Date Posted: 2024-06-11 Location: JPN - Nagoya, Japan Job Description Qualifications: (Japanese Follows) Boeing Research &
The Construction Project Manager is responsible for managing and overseeing construction engineering, planning, and design of all strategic asset investments of Maersk L&S facilities in APA. Working closely with cross-functional teams and external consultants to deliver
