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アボット ジャパン株式会社

会社概要 アボット ジャパン(株)は米国に本社を置き世界130ヶ国以上に事務所をもち91,400の社員を持つアボット社の日本法人です。
医療用医薬品から体外診断薬、医療機器まで製品ラインナップは多岐にわたり、それらの融合により診断から治療までをカバーする「トータルヘルスケア」の充実を目指しています。

★アボットは・・・
1888年ウォレス C.アボットは「人々の治療に役に立つ、より良い医薬品の提供にあたり、もっと良い方法があるに違いない」という強い信条を持ち、創薬医学という新しい科学を切り開き、イリノイ州シカゴからアボットという会社を立ち上げました。
彼の思いは大きく実を結び今は130カ国以上の国で画期的な医薬品ならびに医薬機器の開発、販売を122年以上にわたって行っております。

今でもアボットの事業やサービスの根底にあるものは「CARING」です。 新生児から高齢者まで、すべての人々は健康な生活を望んでいます。これらの人々へ栄養剤から診断薬まで、幅広く提供できることは、アボットの強みであり、使命です。
設立 1962年
資本金 226,700万円
従業員 2,200名

栄養剤製品事業部 RAスペシャリスト

詳細
NEW 外資
仕事内容 【主な職務内容】
信頼性保証部、薬事チームでの、医薬品薬事関連業務
Be in charge of the regulatory related work in Regulatory Compliance department, mainly RA for drug products
As a member of Regulatory Affairs team in Regulatory Compliance department, to be in charge of the regulatory related work, mainly for drug products.
Under guidance/supervision of upper management:
1.To maintain the marketing approvals for the marketed drug products through regulatory procedures through change application and life cycle management activities
2.To prepare the application dossiers for partial change application, minor change notification or new drug applications.
3.To provide regulatory information to the team and other related department.
4.To provide the regulatory advice and regulatory support to other departments’ activities.
5.To support nutrition business strategy through the regulatory assessment
6.To maintain and renew the licenses for business licenses.
7.To review the labeling and promotional materials of the marketed drug products.
8.To execute QC for the regulatory documents (ability of logical QC is more preferred)
勤務地 東京

栄養剤製品事業部 QAスペシャリスト

詳細
NEW 外資
仕事内容 【主な職務内容】
・医薬品、食品の苦情担当
・食品の品質保証業務全般
・原材料メーカー管理、GQP契約のメンテナンス
・品質標準書その他GQP関係書類全般のメンテナンス
・製造委託先のGMP管理
・医薬品申請資料の作成(品質保証部分)とQCチェック
<その他職務詳細>
1.食品委託会社のGMP
・出荷判定業務の補佐
製造会社の製造資料確認、出荷判定用資料の作成・管理
・変更管理/逸脱管理
製造会社との情報のやり取りとドキュメントの作成・管理
・委託会社の監査
・月次メトリックスの作成と委託管理部門QA(アイルランド)への提出
2.シンガポール コマーシャルQAとのコンタクトパーソン
・シンガポール コマーシャルQAとのやり取り
・マネージメントレビュー資料の作成
・その他、シンガポールQAからの要望事項への対応
3.医薬品、食品の苦情処理
・営業部門から挙がってくる苦情報告書の受付
・製造会社との調査のやり取り
・苦情報告書の作成
・苦情内容のシステム(TrackWise)への登録と承認
・委託管理部門QA(アイルランド)への情報提供
4.原材料メーカー管理、品質契約のメンテナンス
・原材料メーカー監査
・品質契約のメンテナンス
・原材料メーカーの変更/逸脱対応
5.品質標準書その他品質保証部門の書類全般のメンテナンス(フォロー)
6.医薬品申請資料の作成(品質保証部分)とQCチェック(フォロー)
・医薬品申請資料の作成(製造、試験方法に関わる部分)
・薬事部門が作成した申請資料の確認
勤務地 東京

栄養剤製品事業部 プロダクトマネージャー

詳細
NEW 外資
仕事内容 Primary Function / Primary Goals / Objectives:
Materialize responsible product’s sales growth through developing product annual strategies, securing field’s execution, and managing the given expense budgets to support activities. Develop future product strategies including the product portfolio management and the product lifecycle management in cooperation with appropriate stakeholders. Be responsible for the product’s demand planning and maintenance of the sales forecast. Contribute to the product’s margin improvement through continuous efforts to evolve the marketing excellence.
勤務地 東京

インフォマティクス事業部 テクニカルサポートマネジャー

詳細
NEW 外資
仕事内容 【Primary Job Function】
Provide high quality Services and Technical Support for STARLIMS products to STARLIMS customers and distributors/partners. Focus on new product technology and functionalities in different areas. Support is provided primarily via incoming emails and telephone calls.
Core Job Description
Provide Services and Technical Support to STARLIMS customers and distributors/partners through email/phone. Occasionally require to provide remote/onsite access Support on customers’ system environments.
Familiar on new STARLIMS features in different areas. As a regional expertise on advanced STARLIMS technology, especially on Instrument interfaces with STARLIMS SDMS and Fusion.
Configure STARLIMS software and configure STARLIMS core product to address customer functional and workflow requirement.
Record all activity in the company’s logging system and update cases in order that progress can be tracked with each ticket.
Perform trouble shooting and implement solution to complex Technical issues. ・Review cases for Technical complexity and make recommendations to team members with regards to escalation according to departmental best practice.
Meet or exceed departmental goals for case management
Phone and emails response times and customer satisfaction scores.

【Position Accountability / Scope】
Demonstrates expertise in a variety of the field's concepts practices and procedures. May provide consultation on complex projects and is considered to be the top level contributor/specialist.
Activities will be under the guidance of Project Manager, Technical Manager.
Supervises and provides direction to other software engineers.
Daily interaction with clients and peer resources.
Must have skills to plan and schedule own work activities and coordinate activities with others software engineers.
Involved with customer presentations customer training or internal training for STARLIMS personnel.
勤務地 東京

エイエムオージャパン株式会社 Supply Chain Planner【東日本】

詳細
NEW 外資
仕事内容 【Primary Function / Primary Goals / Objectives】
1. Works closely with Sr. Planners and Supply Chain Managers to determine target inventory and customer service levels for select products / regions.
2. Evaluates commercial forecasts,historical run rates,marketing Isales information and translates it into a demand plan for AMO & TPM production sites.
3. Communicates with sales,marketing,customer service,TPM's,Logistics,freight forwarders and other cross-functional roles relevant to job.
4. Successfully builds and maintains key relationships with cross-functional teams in their region
【Core Job Responsibilies / Accountability /Scope】
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
1. Reviews actual demand,planning assumptions,and works with regional marketing and sales team to develop the monthly“un-constrained" forecast and demand for products assigned to them. Reviews this demand at the monthly Country Demand Plan (CDP) review or Regional Demand Plan (RDP) review meetings. Provides meeting minutes and demand decisions agreed upon at these meetings.
2. Insures agreed upon demand plan is documented and loaded into the SAP APO planning tool each month in alignment with the Global Supply Chain Sales and Operations planning calendar.
3. Provides a monthly “to manufacturing" or“ to TPM supplier" forecast to appropriate planning teams at these sites and follows up to insure any exceptions or delays are acted upon to prevent backorders in their region.
4. Supports the core teams on the product life cycle impacts of new products within region and communicates any supply impacts that may lead to back-orders or grow excess and obsolete inventory in their region.
5. Participates in projects with operations,marketing,and other corporate functions to drive lead time, cost,and other wastes out of the regional supply chain and customer fulfilment operations.
6. Works within the supply chain team to establish guidelines to obtain target customer service and inventory levels. Communicates with manufacturing and suppliers to solve supply issues. Manages and monitors regional inventory levels and places purchase orders to trigger re-supply to inventory target levels or demand. Performs purchase order maintenance to these orders as needed.
勤務地 東京

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