エスエス製薬 品質保証担当者, Quality Assurance 成田工場
Narita, Japan Permanent Date posted Sep. 19, 2024エスエス製薬 品質保証担当者, Quality Assurance 成田工場
- Location: Narita
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.
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。
組織部門について
品質統括部はエスエス製薬の成田工場に所属しており、成田工場で製造される製品全般の品質保証及び品質管理を管轄しています。今回募集する試験担当者は、試験業務を通して高品質で安心安全な製品供給を行うための品質保証を担います。
Main responsibilities:
主な職責
成田工場における品質保証業務全般。具体的には以下の通り。
(1)医薬品の製造管理及び品質管理の確認
(2)品質管理システムの維持管理(逸脱、CAPA、変更管理、文書管理、バリデーション、教育訓練、品質情報、自己点検、供給業者管理など)
(3)医薬品の工場出荷及び出荷の確認
(4)当局査察及びGlobal Audit(自己点検)対応
(5)新製品Launch Project管理
など
About you
必須要件
- 大卒、又は同程度の一般教養並びに理化学に関する知識
- 品質管理部門(QC)または品質保証部門(QA)での業務経験 1年程度
優遇要件
- 医薬品、化粧品にかかわる 品質管理部門(QC)または品質保証部門(QA)での業務経験
- 固形製剤の生産プロセス(造粒、混合、打錠、コーティングの原理等)の知識
- E-mailや対面での英語コミュニケーション能力（TOEIC：800程度）
- SAP、MES、LIMS、QMSサポートシステムの使用経験
- 薬機法、GMP省令をはじめとする国内のレギュレーション、ガイドラインに関する知識
- 薬剤師免許
求められるスキル
- 業務に支障がないように自他部門において良好な関係を構築できるコミュニケーション
- 専門的な日本語による試験手順の読解
- 上長の一般的な指示のもとに、規則、ルール、マニュアル、手続きに従い、上長へ必要な確認を行いながら定型的な業務を確実に行う
- 前例や規則を論理的に解釈し実行するが、ただ進めるのではなく疑問点・違和感は上長に適切に報告する
- 現状のプロセスや規則に基づいて改善提案を行う
- 業務文書を上長からの指導をうけながら更新する
- Microsoft office(Word/Excel/Power point)の使用
就労環境など（抜粋）
- 雇用形態：正社員
- 勤務時間：8:15~17:00
- 勤務地：成田工場（成田駅から徒歩15分）
- 車通勤：可
- 事業所内食堂：あり
- フレックス制度：あり（コアタイム無）
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.
PursueProgress. 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 and check out our Diversity Equity and Inclusion actions at sanofi.com!
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 'One day at Sanofi' and check out our Diversity Equity and Inclusion initiatives at sanofi.com
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Developing
our talent
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Want to join our Global Talent Community? Every Sanofian works on projects that truly make a difference to people’s lives.
What could you achieve? Sign up today and discover our latest opportunities as soon as they’re available.