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Quality Assurance Manager, Plant in Western Japan Yamaguchi

TBG-019975
Position

03-03 Quality Assurance Manager, Plant in Western Japan/西日本工場 品質管理マネージャー

Company

Life Sciences

Salary(¥):
5-10 million
Responsibilities
1. Management and response of GMP audits / inspections of domestic and foreign customers or regulatory agencies
Collect and analyze quality KPI data and hold regular reporting sessions

2. Create annual review reports, including process trend analysis
Creation of various notification documents and application materials related to the factory

3. The company handles a wide range of products, including drug substances (small molecules), injectables, solid preparations (formulation and packaging processes), vaccines, and drug preparations.

労働時間・賃金の詳細、試用期間の有無、加入保険等の詳細は求職者と面接の際に明示予定

Requirements
 Bachelor's degree or above, majoring in the fields of pharmacy, engineering, science, agriculture, etc., or have equivalent knowledge, experience and skills

<Work experience: essential requirements>

At least 3 years of practical experience in any of the following operations

・ Quality control of prescription drugs or pharmaceuticals

・ Testing and manufacturing technology-related business related to APIs or preparations for ethical drugs

<Specialization: Necessary knowledge>

・ Knowledge of pharmaceutical manufacturing, testing and inspection

・ Knowledge on regulations such as the Pharmaceutical Regulations, GQP and GMP

<Language: Desirable requirements>

・ Business level English (TOEIC 600 or higher, or equivalent)