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信頼性保証本部 品質保証
| Hiring Company | 医療用医薬品スペシャリティファーマ |
| Location | Tokyo - 23 Wards |
| Job Type | Permanent Full-time |
| Salary | 6 million yen ~ 7.5 million yen |
Job Description
【求人No NJB2398411】
医療用医薬品を取り扱う製薬企業において、品質保証業務をご担当いただきます。担当業務は、ご経験やスキルに応じて決定いたします。
主な業務内容
・品質に関する問い合わせ、苦情への対応および必要な措置の実施。
・製造に関連する変更管理や逸脱事象への対応および是正措置の実施。
・製造委託先および外部試験機関に対するGMP監査の実施（海外拠点を含む）。
・製造所とのＧＱＰ取決め締結。
・製造販売承認に関する記載内容の維持管理。
・GQP関連手順書の維持・改訂および補完業務。
・製造販売業許可の更新に伴う査察準備および査察対応。
・出荷判定業務の実施。
General Requirements
| Minimum Experience Level | No experience |
| Career Level | Mid Career |
| Minimum English Level | Business Level |
| Minimum Japanese Level | Native |
| Minimum Education Level | Bachelor's Degree |
| Visa Status | Permission to work in Japan required |
Required Skills
※詳細はご面談時にご説明いたしますJob Location
- Tokyo - 23 Wards
Work Conditions
| Job Type | Permanent Full-time |
| Salary | 6 million yen ~ 7.5 million yen |
| Work Hours | 09:00 ～ 18:00 |
| Holidays | 詳細は求人ご紹介時にご案内いたします。 |
| Industry | Pharmaceutical |
