Ingénieur Qualité Sécurité Environnement in alternance at Cotral Lab, focusing on quality, safety, and environmental responsibilities. Contribute to management system improvements and RSE strategy initiatives.
About the role
- QA Professional providing oversight for projects in Koriyama factory. Ensure compliance with GxP regulations and high-quality standards in pharmaceutical manufacturing.
Responsibilities
- Providing QA oversight and support for projects in Koriyama factory in Japan to ensure timely delivery with the right quality.
- Participating in project and validation activities to resolve quality-related issues.
- Performing quality spot checks and approving validation documentation to ensure the highest quality level.
- Reviewing and approving complex change control requests, SOPs, trend reports, and validation-related documents.
- Preparing annual product reviews and facilitating validation and other complex internal trainings.
- Acting as a coach during audits and inspections, and ensuring compliance with regulations and corporate/local SOPs.
- Providing proactive guidance to departments on quality-related activities and ensuring that current Novo Nordisk procedures and health authority requirements are reflected in quality decisions.
Requirements
- Minimum 5 years’ QA experience, or minimum 7 years’ experience in QC/production or related roles (healthcare/pharmaceutical industry preferred), with a strong quality mindset and solid understanding of QA responsibilities.
- Expert knowledge of quality management systems and cGMP production processes, with deep understanding of validation in pharmaceutical manufacturing preferred.
- Ability to make autonomous, high‑level decisions on complex quality issues and to perform effectively with minimal supervision.
- Strong cross‑functional leadership skills to drive process and team activities and to support others’ ideas and actions.
- Native-level Japanese and business-level English communication skills, both written and oral.
Benefits
- 施設:社員食堂、フリードリンク(ジュースあり)、ジム設備、マッサージチェア、歓談スペース(ビリヤード、卓球台、ダーツあり)
- 休暇:有給休暇は入社日から使用可能(試用期間中でも可)。また、終日や半日以外にも1時間単位での取得も可能。有給休暇は40日(2年分)まで保持可。40日を超えた場合は積立休暇として別途保持が可能。各種特別休暇あり(例:看護等休暇は介護や看護以外に、お子様の学校行事なども含み、有給)
- 各種手当:通勤手当、住宅手当(管理職は対象外)、寒冷地手当、英語研修手当(条件あり)
- 産育休は男女ともに多くの社員が取得(東京本社も)、復職お祝い金もあり(産育休中に受け取る金額が給与より低いので、差額分を補填)
- クラブ活動:最大2つまで補助金対象メンバーとして所属可(3つめ以降は補助金対象外として所属可) 直近の郡山工場でのクラブは、スノーボード、ボルダリング、釣り、バレーボール、キャンプ、ソフトボール、スポーツ観戦、映画鑑賞など。
- キャリアパス:会社の辞令による異動はほぼゼロ、社員自身が自分でキャリアパスを考え、上司と相談して主体的に自己育成を行い、社内公募に応募してキャリアアップをしていく制度と文化が定着。年間の求人のうち、約25%ほどが社内公募で充足(東京本社と郡山の合計)
- 文化:NNwayに基づく採用や評価が浸透し、お互いを尊重した文明的なコミュニケーション(フィードバックはし合うが、適切な表現で伝える配慮のある関係)。年功序列ではなく個々人の努力や発言を大事にしつつ、競争よりも協力を重視する北欧文化。
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