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求人情報詳細

MS&T Expansion Lead RLT Sasayama

求人番号
NJB2225066
採用企業名
日本チバガイギー株式会社
職種

技術系(機械設計・製造技術) - 製造オペレーター(技能職)
技術系(機械設計・製造技術) - 管理職(工場・技術マネジメント)
メディカル・バイオ - メディカルGQP・GMP・品質保証・品質管理

雇用形態
無期雇用
勤務地
兵庫県
仕事内容

【Job Description Summary】
The purpose of the job is to lead and execute the technical activities related to site according to project timeline without delays in the execution. The person must ensure process, technology and product is transferred to the site and will act as the go-to person for MS&T related activities withing the project and during transfer and implementation.
Responsible for technology transfer activities at site level (within, inbound and outbound), including any scale-up or other process adaptations.
Leads technical transfer project team at site and liaises efficiently with involved functions. (e.g. Technical Development, Supply Chain, Production Unit, Quality Control, HSE, other sites)

【Job Description】
Technical transfer milestones achieved in time and in full. Including schedule for registration and launches.
Robust manufacturing process, delivering critical quality attributes.
Analytical methods in place, meeting cGMP standards.
No critical observations during internal and external GMP inspections and Pre-Approval Inspections (PAI).
Adheres to project / Capital Approval Request CAR costs
Stewardship – Manage change control for process transfers and process adaptations and modifications
Validation – Ensure that all relevant technical information and documentation for validation is available.
Launch & Transfer - Act as SPOC on site for technical transfer
Manufacturing Excellence – Contribute to process improvement and optimization for product transfers.
Training - Own the Training Curriculum for own Job Profile and direct reports.
Novartis Manufacturing Manual - Support implementation of Novartis Manufacturing Manual principle 3.


■休日:完全週休二日制, GW, 夏季休暇, 年末年始

求める経験
年齢制限の理由

8 years of relevant experience in pharmaceutical manufacturing; comprehensive know how in pharmaceutical technology, project management experience.
BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree. Desirable MSc. or equivalent experience.
Fluent in English and proficient in site local language


■職種未経験者:不可

年収
800万円 - 1200万円
語学力
英語力:中級以上
受動喫煙対策
就業場所 全面禁煙
受動喫煙対策詳細

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