募集要項
- 募集背景
- An international pharmaceutical company is looking for a Quality Assurance Manager. The selected candidate will lead quality oversight of external manufacturing partners, ensure GxP compliance, and drive continuous improvement across manufacturing and supply operations.
- 仕事内容
-
An international pharmaceutical company is looking for a Quality Assurance Manager.Responsibilities:
* Lead quality oversight for Contract Manufacturing Organisations and act as the primary QA contact
* Review and approve cGMP documents, including Organisations ' batch records, validations, deviations, CAPA, and quality agreements
* Manage product release in accordance with approved specifications and procedures
* Monitor contractor performance using KPIs and escalate adverse quality trends
* Support CMO operational management and pharmaceutical project activities
* Maintain and improve internal quality systems, including site quality reviews and self-inspections
* Ensure compliance with GxP, marketing authorisation requirements, and internal procedures
Requirements:
* Bachelor's degree or above in Pharmacy or Chemistry
* More than 5 years of experience in biopharmaceutical manufacturing or QA/QC
* Experience in GMP, GQP, GDP, validation, batch record review, and product release
* Proficient in biological manufacturing, sterile products, and Japanese dossier review
* Experience communicating with Japanese health authorities
* Native level Japanese; business level English
Preferred requirements:
* Experience in CMC Regulatory and sterile manufacturing
- 応募資格
-
- 必須
-
More than 5 years of experience in biopharmaceutical manufacturing or QA/QC
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY8,000,000.00 - JPY10,000,000.00 per annum
