QA Expert / Quality_Biopharma (Atsugi)

Posted 11 Mar 2024

Atsugi, Kanagawa - Japan

Req Id 272213

Work Your Magic with us! 

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.

 

As a vibrant science and technology company, we believe in science as a force for good. We make a positive difference on millions of people´s lives every day.

ヘルスケア、ライフサイエンス、エレクトロニクスの分野における世界有数の企業です。サイエンスとテクノロジーへのあくなき探究から生まれる革新的な製品・サービスで人々の豊かな暮らしを創造します。

メルクグループジャパンについて、こちらをご参照ください。


 

Position: QA Expert

Location: Atsugi

Department: HC-GM-QCQAB QMS Compliance

Report to: Group Manager of QMS Compliance

Direct report: 0

 

Your Role

QA Expert is responsible to support for establishment and maintenance of overall Biopharma Japan Quality systems at Atsugi site, secondary packaging site of drug products.

The QA Expert is accountable for the quality and GMP compliance of:

Execute local quality control tests including check of packaging component and certificate of analysis according to product specifications and related working instructions.

Maintain product specifications to ensure compliance with approval matters.

Maintain local quality documents to assure documents are in line with global standard as well as local regulatory requirement.

Support training execution according to the annual plan and maintain the training matrix is up-to-date.

Manage site change control project to assure the change is implemented in a timely manner.

Execute self-inspection and supplier audit.

Execute investigation for quality issues such as complaints, deviation, etc. and implement CAPA in a timely manner.

Ensure reporting and escalation of identified risks.

 

Who you are

Education/license

Bachelor above.

Background in pharmaceutical, chemical, physical, or related expertise.

Pharmacist license preferred but not essential.

 

Job Specific Competencies & Skills / Work Experience

Preferably >3 years' experience to handle quality related works under GMP/GQP/GDP/QMS for pharmaceutical, medical device, or related industry.

Experience in participating in PMDA/Prefectural inspection or/and self-inspection preferred but not essential.

Good negotiation skills with internal and external customers.

Good time and priority management skills.

Willingness and enthusiasm to learn and share knowledge.

Continuous improvement mindset, attention to detail, organizational skills.

 

Languages

Native level in Japanese.

Business (preferred), conversational (mandatory) in speaking, reading, and writing in English .

 

Additional Requirements

Basic computer skills (Word, Excel, PowerPoint etc.)

 

 

ポジション QAエキスパート

勤務地 厚木

部署 HC-GM-QCQAB QMSコンプライアンス

報告先 QMSコンプライアンスグループマネージャー

 

業務内容

厚木事業所(医薬品の二次包装事業所)において、QAエキスパートとして、品質システムの確立と維持をサポートする。

QAエキスパートは、以下の品質およびGMPコンプライアンスに責任があります:

製品標準書および関連する作業指示書に従って、包装構成品および分析証明書のチェックを含む現地品質管理試験を実施する。

製品標準書を管理し、承認事項への準拠を確保する。

現地の品質文書を管理し、文書がメルクのグローバルスタンダードおよび現地の規制要件に沿っていることを保証する。

年間計画に従ってトレーニングの実施をサポートし、トレーニングマトリックスが最新であることを維持する。

サイトの変更管理プロジェクトを管理し、変更がタイムリーに実施されることを保証する。

自己点検とサプライヤー監査を実施する。

苦情、逸脱などの品質問題の調査を実施し、タイムリーにCAPAを実施する。

特定されたリスクの報告、エスカレーションの実施。

 

求める人物像

学歴・資格

学士以上

薬学、化学、物理学、またはそれらに関連する専門知識を有する方。

薬剤師免許をお持ちの方は優遇いたしますが、必須ではありません。


具体的な能力・スキル・職務経験

製薬、医療機器、またはその関連産業におけるGMP/GQP/GDP/QMSに基づく品質関連業務の経験が3年以上あることが望ましい。PMDA/都道府県検査への参加経験、または自主検査経験があることが望ましいが、必須ではありません。

社内外の顧客との折衝能力のある方。時間管理、優先順位管理ができる方。

知識を学び、共有する意欲と熱意がある方。継続的な改善マインド、細部へのこだわり、整理整頓能力。

 

語学力日本語ネイティブレベル

ビジネスレベル(歓迎)会話レベルの英語力(必須)
その他の条件基本的なパソコンスキル(ワード、エクセル、パワーポイント等)

 

Recruiting Contact: Maiko Yamasue

 


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What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

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