社名
社名非公開
職種
品質保証、品質管理
業務内容
希少疾患領域
新製品ローンチに携われる
求められる経験
•Strong hands-on GMP/GQP, New Product introduction, Quality Assurance / Compliance experience in pharmaceutical industry.
•Exceptional Global communication and interpersonal skills, and ability to work globally in a matrix environment.
•Business English level
...
•Accountability and commitment for outcomes and project completion
•Thorough knowledge of applicable local and global regulatory requirements required for GxP compliance and new drug application (NDA).
•Thorough knowledge of GMP/GQP; Product release, Change control, Complaint management, and Quality agreements.
•Thorough knowledge of CMC science such as the process validation, QC testing and so on
•Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
•Holistic understanding on a broad range of pharmaceutical activities and Quality Systems.
•Strong stakeholder management skills
保険
健康保険,厚生年金保険,介護保険,雇用保険,労災保険
休日休暇
日曜日,土曜日,祝日
給与
年収700 ~ 1,100万円
賞与
-
show more
社名
社名非公開
職種
品質保証、品質管理
業務内容
希少疾患領域
新製品ローンチに携われる
求められる経験
•Strong hands-on GMP/GQP, New Product introduction, Quality Assurance / Compliance experience in pharmaceutical industry.
•Exceptional Global communication and interpersonal skills, and ability to work globally in a matrix environment.
•Business English level
•Accountability and commitment for outcomes and project completion
•Thorough knowledge of applicable local and global regulatory requirements required for GxP compliance and new drug application (NDA).
•Thorough knowledge of GMP/GQP; Product release, Change control, Complaint management, and Quality agreements.
•Thorough knowledge of CMC science such as the process validation, QC testing and so on
•Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
•Holistic understanding on a broad range of pharmaceutical activities and Quality Systems.
•Strong stakeholder management skills
保険
健康保険,厚生年金保険,介護保険,雇用保険,労災保険
休日休暇
日曜日,土曜日,祝日
給与
年収700 ~ 1,100万円
賞与
-