募集要項
- 募集背景
- An international pharmaceutical company is looking for a QA Manager. The chosen individual will develop operating procedures aligned with relevant regulations.
- 仕事内容
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An international pharmaceutical company is looking for a QA Manager.Responsibilities:
* Develop operating procedures in line with relevant regulations
* Play a role in overseeing external partners and contributing to company objectives
* Lead projects related to external product transfers
* Support various aspects of quality management for product launches and ongoing activities
* Manage systems related to quality and compliance
* Assist in inspections and collaborate with colleagues
* Provide oversight to external manufacturing partners
* Contribute to the implementation of quality management systems
* Support audit program management for key suppliers
* Assess and monitor regulations and standards related to quality and testing
Requirements:
* Bachelor's degree or above
* 2-5 years of experience in quality assurance and quality-related field
* Experience conducting GMP audits of laboratories that perform analytical testing of biologics, LSPs, and packaging suppliers
* Prior experience in pharmaceutical or biologics product commercialization and lifecycle management
* Understanding of regulatory authority inspection processes
* Ability and willingness to travel internationally
* Proficient in Japanese and English
- 応募資格
-
- 必須
- 2-5 years of experience in quality assurance and quality-related field
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY10,000,000.00 - JPY13,000,000.00 per annum
- 休日休暇
- weekends off, public holidays, paid holidays