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| 部署・役職名 | JAPAC MAH QA Manager／Specialist（品質本部 品質保証部） |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
業務内容 ●Provide advice on QA tasks based on experience. ●Communicate with health authorities and respond to inquiries. Coordinate NDA/sNDA/GMP clearance and other documents. ●Takeover of monitoring of distributors, compliance and repackaging instruction review and approval. Supplier quality management, QA artwork tasks. System administration / BPL activities of eQMS. ●Communication with distributors, GMP/GDP compliance activities （changes, deviations, shipments, inspections） Monthly reporting and metrics, internal audit and inspection. subsidiaries, partners and distributors. ●Other tasks related to their organization or function that are reasonably necessary, as well as organizational skills development （human resource training and organizational development）. ■採用背景： In order to realize ”Continuous Creation of Life－Changing Value” as stated in our Vision 2030 announced in February 2024, we have decided to integrate the APAC region into the JP region as of January 1, 2025 as ”Story for Vision 2030. We must continue our quality assurance activities and contribute to patients. |
| 労働条件 |
勤務地 本社 住宅補助（エリアや条件により補助額が異なる）：78,000円（東京・独身・最大額）116,000円（東京・3人以下・最大額）、143,000円（東京、4人以上・最大額） |
| 応募資格 |
【必須（MUST）】 語学要件●Negotiation and consensus－building English language skills required ●Continuous improvement of Japanese skills is required 必要な業務スキル、経験 ●Basic expertise in Post Approval Quality Assurance is required ●GMP Experience is required （at least 3 years, QA/QC/Manufacturing） ●Sufficient knowledge and practical experience in pharmaceutical applications is desirable ●Requires an understanding of the latest developments in GMP/GDP/GQP/Related regulations ●Learning to develop an understanding of the manufacturing processes of key products is recommended 求める人材像 ●Communication and coordination skills to build good relationships with stakeholders and related parties to drive operations, and willingness and negotiation skills to face individual cases are required |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2024/08/08 |
| 求人番号 | 3765200 |
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です