Job Description

Company Overview
Pharmaceuticals Company

Job Description

・Arrange quality agreements between manufacturing sites where
approved products are manufactured. Confirm if and proper product/quality control is enforced by periodical on-site audits. Manage manufacturers by instructing for improvements if necessary.
・Support Quality Assurance Supervisor for the product release to
market by the proper evaluation for production control and quality control. ・Plan and execute the CAPAs for quality improvements and deviations
by analyzing the information related to the product quality.

・医薬品医療機器等法、GQP 省令、GMP 省令、関連法令に関する知識。
・外国製造業者の認定または認定更新、定期的な GMP 適合性調査申請等の薬事申請に関する知識。
・3 年以上の GQP または GMP 業務の経験

・Knowledge of PMD Act., GQP/GMP ministerial ordinances, and related
・Basic knowledge of DS/DP manufacturing, packaging operation, quality control testing and Japanese Pharmacopoeia.
・Knowledge of accreditation/renew of accreditation for foreign manufacturer, regulatory application for periodical GMP compliance inspection etc.
・GQP or GMP operations more than 3 years
・Experienced in working in a highly matrixed organization and working closely with the global team