336075BR
Jan 13, 2022
Japan

Job Description

Candidates can learn entire medicine life cycle management. the candidate also can improve his/her communication skill in both Japanese and English as the role needs to collaborate global production sites, CPO and government.

Your responsibilities:
-Ensures, defines and governs consistent master data throughout the whole master data life cycle and global business processes and defines the matrix of responsibilities within the MD process and the person that defines the parameter, the person who updates SAP with the right value, etc
-Ensures that local material master data integrity and quality is established by analyzing basic requirements, maintaining the attributes in the systems and assuring all data introduced in the system is reliable and comes from the correct sources and challenges data consistency and completeness and verifies, correct and completes requests for data maintenance complying with Global Master Data processes and related SOPs.
-Identifies areas for improvement regarding Global Material Master processes, tools and rules and supports improvement processes.
-Responsible for specific Master Data Management processes (expertise, key account) to build, extend and share knowledge within self-directed working teams. -Train and support the assigned functional SPoCs and Subject Matter Experts on site and ensure compliance with GMP and regulatory requirements (including record management) and continuous improvement of quality relevant processes within area of responsibility.
-Ensures permanent data quality and assists in data base cleaning.
-Ensure material availability in line with the approved production plan.
-Ensure daily MRP oversight for all BOM material, analysis of requirements and Purchase Orders management.
-Ensure management of daily MRP exception messages & appropriate follow up. -Own, in ERP System, MRP relevant data and materials technical specifications and ensure no Purchase Orders are past due in the ERP System.
-Management of purchased item Complaints/Returns to supplier.
-Provide a load -balanced dispatch list for incoming materials to the warehouse and Quality department that ensures these activities are completed in line with the production needs.
-Control and follow-up of supplier’s service level indicators: Quality OTIF, lead-time violation.
-Lead action plans to achieve supplier delivery performance targets and drive for continuous improvement.
-Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

薬事法の条件を満たして生産を開始させるための、プロジェクトの推進。
 工場内、Global、委受託先と調整を行い、生産体制を確立する。
 HSE基本情報の業務遂行への反映。
 中長期におけるプロダクトポートフォリオの明確化とそのライフサイクルマナジメントの実施。
 NOSSCE S&OP Product Review Meetingのミーティングファシリテーターとして会議体の推進を行う。
 MARSのSPoCとして、品目コードの登録から廃止までのライフサイクルマネジメントに対する責任を有する。

What you will bring to the role:
This is a position to manage medicine's life cycle.
The role impacts to medicine launch till the closure that impacts to medicine delivery and quality

・新規上市品目の円滑な導入
・会社方針と合致した施策の推進
・中長期におけるプロダクトポートフォリオの明確化とその適正マネジメントの推進

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

Operations Management and Execution Project Management Collaborating across boundaries
English Master Data Governance Product Life Cycle Management Inventory Management Supply Planning Order Management Transportation Knowledge of relevant tools and systems

 GMP文書の概要を理解し、工場全体に及ぶGMP知識を有している。
 自部署に関連するGMP文書の作成・点検・維持・管理等の業務及び査察対応ができる。
 薬事法、向精神薬取締法の基礎知識を持つ。
 Quality Manualの基礎知識を持つ。
 製品の上市に必要な手順を理解し、工場内の関係者をリードしながらプロジェクトを遂行できる。
 新製品の導入にあたり、製剤の安全性情報を開発部門に確認し、安全な製造作業が実施できるよう必要な情報を入手する。

Languages:Japanese: Excellent Japanese writing and oral communication skills
English: Fluent in writing and speaking
 英語でのコミュニケーション能力

About Novartis Japan:
Novartis Pharma KK operates as a pharmaceutical company. The Company develops, produces, imports, and sells prescription drugs, over-the-counter medicines, and health-care products. Novartis Pharma's products are used in cardiovascular, cancer, respiratory, and central nervous systems.
Workplace benefits:
Attractive office location, flexible time management, strong work/life balance, flexible working hours, truly multinational and dynamic organization, multicultural environment and cross-functional hub location
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Why consider Novartis?
799 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous, and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Novartis Technical Operations
NTO LOCAL MARKET MANUFACTURING
Japan
Sasayama
Technical Operations
Full Time
Regular
No
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336075BR

Associate, Lifecycle Manager ,Sasayama

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