メディカル・バイオ - メディカルGQP・GMP・品質保証・品質管理
メディカル・バイオ - 品質保証

【Role Overview】

Quality assurance related work for medical devices, pharmaceuticals, etc.
 Comply with laws and regulations, improve/maintain product quality, and realize the "Quality Policy."
医療機器及び医薬品等の品質保証関連業務
 法規制及びコンプライアンスを遵守し、製品の品質を改善／維持し、「品質方針」を実現する。

1. Manage market quality information in accordance with relevant regulatory laws, such as the Pharmaceuticals and Medical Devices Act and QMS/GQP minutes.
(1) Create and maintain agreement books with manufacturers
(2) Create and maintain product standard books
(3) Change management, deviation processing, corrective and preventive measures, quality information response
(4) Obtain necessary information on product quality from domestic manufacturers
(5) Create required procedure manuals for QMS/GQP
2. With support as needed, work with manufacturers to investigate quality information on medical devices manufactured in Japan, and continuously improve and maintain product quality.
3. As the QSR (Quality System Representative) for CSV, evaluate CSV-related documents. In addition, provide appropriate advice on CSV implemented by related departments and ensure proper response.

1. 薬機法、QMS／GQP省令等、関連する法規制に則って、市場品質情報を取り扱う。職務を行うにあたり、主として下記を運用する。
(1)製造所との取り決め書の作成・維持管理
(2)製品標準書の作成・維持管理
(3)変更管理、逸脱処理、是正・予防措置、品質情報対応
(4)国内外製造所からの製品品質に関する必要情報の入手
(5)QMS／GQP上必要な手順書等の作成
2. 必要に応じてサポートを受けながら、国内外で製造する医療機器等について、製造所の担当者と連携して品質情報を調査し、継続的に製品品質を向上、維持管理する。
3．CSVのQSR(Quality System Representative)として、CSV関連文書を評価する。また、関連部門で実施するCSVに関しては、適切にアドバイスするとともに、確実な対応を促す。

1. Pharmaceuticals and Medical Devices Act, QMS/GQP Ministerial Ordinance, and other related laws and regulations
2. Able to communicate smoothly with site personnel in Japan and overseas.
3. English skills necessary to carry out work (ability to communicate via email, conference calls, and understand global SOPs)
4. PC skills: Microsoft Office

1. 薬機法、QMS／GQP省令等、関連する法規制
2. 国内外のサイトの担当者と円滑にコミュニケーションを図ることができる。
3. 業務を遂行する上で必要な英語力（メールでのコミュニケーション、電話会議でのコミュニケーション、グローバルのSOPが理解できる）
4. PCスキル　Microsoft Office

■休日：完全週休二日制, 年末年始

• Experiences:
- Strong QA experience for 5 years+ in pharmaceuticals and medical device field.
- Longer than 3 year experience in Pharma GQP and GMP

• Ability/Skills:
- Knowledge of GQP/QMS ministerial ordinance and related laws with QMS/ISO13485 process.
- Ability to handle complex problems/projects by exercising independent decision making and analytical thinking skills within generally defined practices and policies
- Flexible and adaptable with strong conflict management skills.
- Ability to work independently under pressure and prioritize multiple tasks
- Ability to lead and influence, and to support others within team
- Good organizational skills with people management
- Good written and verbal communication skills in Japanese and English

Competencies & Licenses (required qualifications and licenses)
• Pharmacist (Preferable)
• TOEIC 750 equivalent or higher
• Equivalent to MS Excel/Word Expert
• Knowledge of Power automate, Power apps, Power BI, etc. (preferable)

■職種未経験者：不可