仕事概要
| 職種 | 技術職（販売、設計、開発、生産管理）／生産管理、品質管理、施工管理、EHS、PMS |
|---|---|
| 業種 | 医療／ 医療機器 |
| 雇用形態 | 未分類 |
| ポジションレベル | その他 |
| 募集人数 | 1名 |
| 希望入社時期 | - |
| 必須語学力 |
日本語 （流暢に話せるレベル） 英語 （ビジネスレベル） |
| 活かせる語学 | - |
| 勤務時間 | その他 |
| 福利厚生・休暇 | |
| ビザ取得支援 | - |
| 外国人従業員 | - |
仕事詳細
Company Overview
Medical Devices Company
Job Description
• New drug application for approval
• Gap analyses of dossiers provided by overseas sites in comparison with Japanese regulations
• Communication with HAs (negotiations/consultations/meetings)
• GMP application for approval for new drug application/PCA/periodical GMP compliance application
• New application/Renewal of FMA
• Preparation of QA agreement under GQP ordinance
• Manufacture site audit under GQP ordinance
Requirements
Preferable (not mandatory)
• More than 5 years of experience of CMC/Regulatory CMC and more than 2-3 years of experience of QA for pharmaceuticals
• Experiences with MD submission including STED preparation
• Pharmacist
Organizational Knowledge
• Understand the company systems and processes – QA, QC, Marketing, Sales, Customer service, IT, HR, GA, Finance, Manufacturing, Supply chain, Warehouse, Technical Center
• Understand the global culture and different business manner
面接について
連絡先
CMC RA/QA Manager
RGFタレントソリューションズ株式会社
1000 〜 1200 万円
