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| 部署・役職名 | 郡山工場 IT Quality Professional＜福島県外の場合は週1出社で新幹線通勤可能＞ |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
・As IT QA for systems, you will handle and approve deviations, as well as change requests related to IT systems. Identify compliance issues and take initiative to having them closed timely, and provide recommendation in relation to quality evaluations and other quality tasks. ・Contribute to validation planning, including IT risk management and conclusion of appropriate validation strategy. ・Review and approve key deliverables according to validation planning. You will also establish and maintain quality oversight related to the system or services to ensure compliance with internal and external requirements, in collaboration with IT System Owner. ・Assist in SOP （Standard Operating Procedures） content to identify and remove unnecessary complexity in the process, as well as in IT related documents. Partner with Novo Nordisk Quality to drive initiatives to improve IT qualification and maintenance practices within the organization. ・Preparation of documentation related to IT systems and presentation in audit and inspections. Participate in follow up of findings and development of action plans related to IT systems. ・Represent Quality in relevant projects and contribute to finding the right solutions. Provide Quality and IT expertise during projects in Koriyama Factory. Ensure excellent collaboration within stakeholders in the organisation and participate as QA in digitalization projects both in KFA and in global. 補足：IT未経験でも入社後半年間Denmarkへ行ってIT教育を受けて頂くことを前提に選考致します。 郡山で長期のキャリア形成をお考えの方はご相談下さい。 |
| 労働条件 | 詳細は面談でご説明致します。 |
| 応募資格 |
【必須（MUST）】 ・バリデーションとITリスクアセスメント経験・At least 5 years of experience working with IT systems such as SAP, MHS or LIMS. ・Experience with quality standards within IT systems （validation experience is a must） and experience working at factory. ・Knowledge of Japanese IT requirement “コンピュータ化システム適正管理ガイドライン”. Experience with general standards （GMP and ISO, specifically ISO9001 and ISO13485） are preferred. |
| 受動喫煙対策 | 喫煙室設置 |
| 更新日 | 2024/02/29 |
| 求人番号 | 3325698 |
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- (2024/03/21)
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