募集要項
- 募集背景
- ・Provide leadership of the Quality Assurance functions for Active Pharmaceutical Ingredients (API) & Oral Solid Dosage (OSD) manufacturing, and Warehouse/Distribution. Develop and drive mid and long-term strategy and operational excellence, training/education, talent review and personnel development.
- 仕事内容
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・Responsible for and manage all aspects of API/OSD/Warehouse Quality Assurance at the facility, ensuring that quality systems, processes and related functions are in place and meet current Good Manufacturing Practices (cGMP), Takeda and other regulatory quality standards and requirements.
・Approve and manage site deviation investigations and assess product impact
・Drive API/OSD GMP adherence on the shopfloor in manufacturing areas
・Drive and manage the application of strategic goals
・Achievement of defined goals and targets in order for the Hikari plant to reach operational and compliance excellence
・Responsible for timely and effective communication and escalation processes to the Site Quality Head in order to raise quality and safety issues
・Responsible for the department expenses and department budget planning
Ensures adherence to the EHS program
- 応募資格
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- 必須
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・Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biology or related discipline.
・At least 10 years of management experience in the following areas in the pharmaceutical in-dustry: Quality assurance, Quality Control; understanding of the requirements for manufactur-ing, plant utilities, computer systems and project management.
・In depth knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines.
・Knowledge in areas related to Manufacturing, Finance, EHS and HR (incl. Labor law)
・Strong leadership skills (i.e. Communication, Coaching, Project Management, ・Decision Making, Problem Solving, Team building and etc.)
・Business level English skills are necessary (both verbal and written)
- 歓迎
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Preferred:
・License for pharmacist
・MBA
・Experience of overseas assignment.
・Preferred to have experience in managing team with applicable EHS perspectives such as waste, waste water, exhaust gas, noise, GHG reduction, health, and safety. (5 years for department head and 3 years for Group Managers)
・Preferred to have experience in ISO 14001/45001 management system to carry out continuous improvement of site.
・Some travels will be required.
・This job description is not designed to be a complete list of all duties and responsibilities required of the position.
- 雇用形態
- 正社員
- 勤務地
- 山口県
- 勤務時間
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勤務時間：本社（大阪市中央区・東京都中央区）9:00～17:30 、
工場（山口県光市・大阪市淀川区）8:00～16:45 、（千葉県成田市）8:45～17:15 、
研究所（神奈川県藤沢市）9:00～17:45
フレックスタイム制、テレワーク勤務制あり（対象社員）
- 年収・給与
- 年俸1200万円 ～ 2200万円
- 待遇・福利厚生
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諸手当：通勤交通費、借家補助費、社宅など
社会保険・労働保険（健康保険、厚生年金保険、雇用保険、労災保険）
昇給：原則年1回
賞与: 原則年2回
- 休日休暇
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土曜、日曜、祝日、メーデー、年末年始など（年間123日程度）
休暇：年次有給休暇、特別有給休暇、傷病休暇、ファミリーサポート休暇、産前産後休暇、育児休暇、子の看護休暇、介護休暇
- 選考プロセス
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書類選考
1次面接
Webの適正テスト
2次面接
