quality assurance senior manager (大手外資系製薬会社).

Summary of Job Duties & Responsibilities:- Ensure quality control, monitoring, and development of systems and procedures across multiple disciplines, leveraging extensive subject knowledge and experience in various quality areas.- Manage and oversee quality assurance systems, leading a team of quality professionals to ensure compliance and enhance quality approaches.- Perform tasks related to Good Quality Practice (GQP) and Good Distribution Practice (GDP), including SOP creation, contractor management, product shipping, and quality assurance in the distribution process.- Collaborate with global departments to gather accurate information from overseas manufacturing facilities, ensuring CMC compliance and GMP review.- Handle change management applications for approved products, and prepare appropriate budgets and proposals for quality assurance initiatives.

求められる経験

- Minimum 5 years work experience in GQP/GMP work at a pharmaceutical company.
- Minimum 5 years of experience in GQP/GMP work for products of biological origin.
- Must have knowledge of pharmaceutical regulations for products of biological origin including GMP and CMC after the amendment in 2005.
- Bachelor’s degree or higher in pharmacy or science major.
- Proficiency in English to communicate with Global staff. (conference call, email)

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1,000 ～ 1,300万円

賞与
-
雇用期間
期間の定めなし