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新着求人 生産技術  (MF-60)
募集職種 外資系製薬企業の New Product Introduction Project Manager
その他のGMP生産管理・技術の求人はこちら
勤務地 静岡
会社概要 非公開
求人要件 The * NPI Project Staff reports to the * NPI Lead and is responsible for managing NPI projects in the * manufacturing facility from beginning to launch. This includes coordinating and ensuring supply chain support is provided to any activities prior to project start at * . The NPI project staff may also support other activities as required.
法規制の順守に関する責任REGULATORY COMPLIANCE RESPONSIBILITIES:(If needed)
The * NPI Project Staff needs to have a fundamental understanding of GMP and be aware of:
•The Drugs and Medical Devices Law in Japan
•Poisonous and Deleterious Substances Control Law in Japan
•Narcotics and Psychotropics Control Law
•Others – as required
職務の詳細ESSENTIAL DUTIES:
The * NPI Project Staff is responsible for the following:
•To coordinate and ensure the correct supply chain resource is available to provide the right inputs at the feasibility stage of projects (including confirmation of manufacture at * or otherwise).
•To lead the kick-off meeting for new products and ensure the appropriate team members/functions are present.
•Ensure key project milestones are defined and the initial project baseline is set.
•To continuously track and ensure the timely completion of work packages and project tasks.
•To keep a log of and escalate in a timely manner issues and risks as they arise.
•To resolve conflicts and ensure the project team continues to operate together, in an efficient manner.
•To provide frequent status updates of their project portfolio to the NPI Lead and Technical Operations Lead.
•To ensure the appropriate information flow within the project team, and:
•Between the relevant functions within the site
•Between functions across sites
•With above site teams, including global and regional functions
•To support the Technical Operations team in internal and external audits
•To continuously support the NPI Team Lead to develop and improve the NPI project processes, reducing, where possible, the overall time required to take a product to market.
【必要とする能力・スキル】
教育/経験EDUCATION/EXPERIENCE:(Essential)
•Engineering based degree (Chemical/Process engineering, Biopharmaceutical engineering, Mechanical Engineering), OR
•Science based degree (Chemistry, Biology, Physics, Biochemistry, etc.), OR
•Equivalent demonstrated experience
•Project management experience
•Fluent in English
教育/経験EDUCATION/EXPERIENCE:(Desirable)
•Pharmaceutical drug development, technical transfer and new product introduction experience preferred
•Fluent/Native Japanese language level preferred
募集背景  
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