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／ その他医療 |
| 雇用形態 | 未分類 |
| ポジションレベル | 本部長/経営層レベル |
| 募集人数 | 1名 |
| 希望入社時期 | - |
| 必須語学力 | |
| 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
◆グローバルランキング5位以内
◆ヨーロッパヘッドクオーター
◆癌、呼吸器、循環器、眼科領域を始め幅広い領域にパイプラインを持つ
◆癌領域に最先端の技術
Job Description
Job Purpose
・ Responsible for managing quality aspects at Apheresis sites and transporter for Apheresis materials
・ Training of sites on QA aspects
・ Ensure that all aspects of the handling, manufacturing and distribution of apheresis materials are in compliance with the Company's Standards, with the effective Quality Agreement. Ensure that activities at apheresis site and transporter are conducted according to the relevant SOPs.
・ Coordinate sites for internal audit.
・ Communicate directly with Cell processing site (Morris Plains) to handle deviations at Apheresis site
Major Accountabilities
・ Compliant running sites
・ Passing of internal/external audits
・ Manufacturing not interrupted because of non compliant operation
Requirements
・ Bachelor or higher in Biology, Biochemistry or another related science
・ Fluent in speaking / writing in English
・ Experience in QA Operations, production, QC and/or regulatory other relevant operational areas, but must include minimally 5 years in QA, and 3 years of management and or project management experience
・ Knowledge of cGMP requirements
・ Strong understanding of regulatory requirements for commercial products
・ Proven track record with PMDA and other Health Authorities
・ Strong Technical understanding of pharmaceutical processes
面接について
連絡先
Manager, Quality Assurance, Cell & Gene (CAR-T)
RGFタレントソリューションズ株式会社
900 〜 1400 万円
