Job Information
Sanofi Group エスエス製薬 GQP Group, Japan Country Quality in Tokyo, Japan
エスエス製薬 GQP Group, Japan Country Quality
- Location: Tokyo, Japan
エスエス製薬について
「全ての人々の健康を願い、革新による価値の創造を追及し、信頼され、親しまれるコンシューマーヘルスケアの担い手を目指す」をミッションとし、OTC医薬品（一般用医薬品）をお届けする製薬会社として、エスエス製薬は1765年の創業以来、人々の健やかで明るい暮らしに、革新的な製品と確かな製剤技術で応えてきました。
高齢化社会を迎え、生活者の健康志向が高まる中、「セルフメディケーション」の浸透はその重要性を増しています。また、ライフスタイルの多様化により、生活者の視点に立った製品開発が、一層求められています。このような中、エスエス製薬は「顧客志向」を徹底し、「スイッチOTC医薬品」をはじめとした革新的な製品開発と、生活者ニーズに対応した情報提供によって、皆さまの健康と生活の質の向上に貢献しています。
About the job
At Sanofi Consumer Healthcare, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities, while also contributing to a healthier planet. We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world.
Main responsibilities:
Sanofi CHCグローバル品質基準および適用されるGxP規制要件に準拠した品質プロセスと活動が実施されることを保証するために、日本のCHCコマーシャル組織全体でCHCアフィリエイト品質システム (GxPおよび健康規制活動を対象とする) の実施と保守を主導し管理する。
- Lead and manage the implementation and maintenance of the CHC Affiliate Quality System (covering GxP and health-regulated activities) across the local CHC Commercial organization, to ensure that quality processes and activities in scope are executed in compliance with the CHC Global Quality standards and applicable GxP regulatory requirements.
患者・顧客の安全を確保するため、安全、効率的、高品質なCHC製品、情報、サービスを確実に提供し、品質ビジネスパートナーとしてビジネスプロフェッショナルをサポートする。
- Secure delivery of safe, efficient, quality CHC products, information & services to ensure patients/customers safety and act as Quality Business partner to support business priorities.
GQP省令で定められた次の品質保証業務への参画/管理
- Participation in/management of the following quality assurance tasks as defined by GQP ordinance；
逸脱、苦情処理を含む品質情報管理、変更管理、市場への出荷管理
製造業者等へ法令及び社内規定に基づいた適切なアクションの指示及び実行
製造業者等（海外含む）への監査
自己点検業務
関連する手順書や報告書の作成
Quality information management include Deviation, Product complaint, change control, and market release management
Implementation of appropriate instructions and actions for manufacturers based on Regulatory compliance and Sanofi QD
Auditing manufacturers (including overseas)
Self-inspection
Preparation of relevant SOP, procedures and reports
About you
Knowledge and Skills
・医薬品等の品質管理（GQP）および製造管理（GMP）に関する知識
Knowledge of quality assurance (GQP) and/or manufacturing control (GMP) of pharmaceuticals.
・英語スキル：ビジネスレベル
English (business level or daily Conversation level)
・日本語スキル：ネイティブレベル
Japanese (native level)
Experience and/or Certifications
必須要件 Required
・医薬品の品質保証（QA）に関する経験3年以上. もしくは、医薬品の品質管理（QC）、医薬品の製造管理に関する経験5年以上
Required: Not less than 3 years’experience in quality assurance of Pharmaceutical products. OR Not less than 5 years’experience quality control and production control of pharmaceutical products
Why choose us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Pursue Progress . Discover Extraordinary .
Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.
At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !