Quality Assurance, JAO GDP

募集要項

仕事内容

•Supports the maintenance and enhancement of the global company GDP QA Quality Management System (QMS) related activities through cross functional team working, specifically self-inspection, KPI monitoring and quality management review processes.
•Ensures timely documentation of GDP related nonconformances in TrackWise digital with root cause identification and actions for prevention as well as appropriate affected batch disposition based on quality and safety perspective.
•Assesses and approves GDP related changes in TrackWise digital.
•Reviews and approves transportation study documents prepared for new product launch and GDP relevant changes.
•Quality oversight of contracted 3PLs and Freight Forwarders to ensure their quality management system is maintained and enhanced through nonconformance/CAPA management, Business Review Meeting, Auditing, Quality Agreement maintenance and periodical GDP Risk Assessment.
•Ensure company's products are distributed in a timely manner through Usage Decision in SAP S/4 in collaboration with JP affiliate QA, SCM and distribution centers.

応募条件

【必須事項】

•Minimum BA/BS (Pharmacy, Medical or Biomedical/Life Sciences preferred) preferably with an advanced professional degree
•Track record of demonstrable and relevant minimum 3 years’ experience within QA, specifically GMP/GDP areas.
•Good understanding of establishing and maintaining (GxP) Quality Management Systems.
•Proficiency in local language (Japanese) and business English language (written, verbal, presentation, facilitation)
•Ability to represent the company to external stakeholders.
•Ability to apply industry knowledge and interpretation to anticipate global impact and contribute ideas for strategies and levels of management.
•Ability to develop and maintain effective relationships with internal and external stakeholders including Global company's entities.
•Can develop / execute quality strategies with management guidance.
•Makes decisions for the department in their area of quality expertise with management oversight.
•Good communication and negotiation skills and willing to build collaboration relationships.
•Good problem-solving and solution-oriented skills.

【歓迎経験】

・ SAP（S4 Hana）およびBloombergの使用経験
・ グローバルキャッシュマネジメントシステムの導入経験
・ 変革プロジェクトを主導した経験があり、成功実績がある
・ ジュニアメンバーへのコーチングおよびトレーニングの経験

【免許・資格】

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

試用期間原則なし

勤務地

転勤の有無

転勤なし

受動喫煙防止措置

屋内禁煙

勤務時間

フレックスタイム制
フルフレックス（コアタイムなし）
8:45～17:45（月～木）、8:45～16:00（金）

勤務開始日

応相談

休日休暇

完全週休2日制
年間有給休暇：　
法定休暇：年次有給休暇、産前産後休暇、介護休暇
特別休暇：夏季休暇、年末年始休暇
その他休暇：祝日、5月1日　育児休業制度

年収・給与

年収　　800万円～　経験により応相談

諸手当

裁量労働手当、住宅手当、通勤手当　等

昇給

あり

賞与

あり

採用人数

若干名

待遇・福利厚生

通勤手当：有
寮・社宅：有
住宅手当：有

各種制度

雇用保険：有
労災保険：有
厚生年金：有

選考プロセス

１）書類選考
２）一次面接
３）最終面接