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| 部署・役職名 | 【大阪工場】 品質システム・コンプライアンス担当(課長代理/一般社員) |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
[OBJECTIVES/PURPOSE] Lead and manage the associated function as a Lead Specialist on QS&C Drive collaboration across the group/department to proactively solve problems and continuously improve processes Develop talents and promote open culture to activate the teamwork [ACCOUNTABILITIES] Lead and manage QS&C activities assigned from the below and specified in GMP Job Description Responsible for construction and maintenance of document structure of the Site. Responsible for owning, explaining and training of Process for “Good Documentation Practice” Responsible for preparing of annual GMP training plan. Develop, Improve and explain Learning management system. Supervise training coordinators of each department. Introduce innovative training methodologies at the site Business Process Owner for Complaint Handling related SOPs Manage inspection readiness, handling and follow up Lead preparation of PQRs and review of PQRs Manage preparation of regulation documents in a timely manner Responsible for review of assessment and action plan in change control system. Manage and handle change control for timely completion. Explain and train change control system as business process owner. Responsible for review of Validation master plan, protcol and report. Explain and train Validation as bussiness process owner. Manage and promote Data integrity. Manage and prepare Quality Agreement for MH / vender in a timely manner. Manage qualification process of new vender. Manage qualified venders to keep the status up to date. Lead and involve team members with priorities, action plans, expected roles, and schedules to get them motivated and committed Develop and help talents be prepared for next functional lead position with multiple skills Assists/Involved/Lead in the identification and implementation of continuous improvement opportunities (AGILE) |
| 応募資格 |
【必須(MUST)】 High school diploma or higher diploma. Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biology or related discipline is preferred. Have knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines. Leadership, people management and technical capabilities Business level of English skill is preferred (both verbal and written) Manufacturing knowledge for the product territory which this job covered. |
| アピールポイント | 自社サービス・製品あり 日系グローバル企業 女性管理職実績あり 上場企業 従業員数1000人以上 創立30年以上 年間休日120日以上 産休・育休取得実績あり ストックオプション制度あり 教育・研修制度充実 資格支援制度充実 |
| リモートワーク | 不可 |
| 受動喫煙対策 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2026/01/15 |
| 求人番号 | 6405712 |
採用企業情報
- 武田薬品工業株式会社
-
- 資本金1,676,200百万円
- 会社規模5001人以上
- 医薬品メーカー
-
会社概要
【設立】1925年1月29日
【代表者】クリストフ・ウェバー
【資本金】1兆6,762億円 ※2022年3月末時点
【従業員数】5,149名 ※2022年3月末時点
【本社所在地】東京都中央区日本橋本町二丁目1番1号
【その他事業所】大阪、神奈川、山口、千葉、京都
【事業内容】医薬品等の研究開発・製造・販売・輸出入
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