募集要項
- 募集背景
- A global pharmaceutical organisation is looking for a QA Manager. The selected candidate will lead quality assurance activities across CMOs, ensuring GMP compliance, product quality, and stable supply while working closely with internal and global stakeholders.
- 仕事内容
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A global pharmaceutical organisation is looking for a QA Manager.Responsibilities:
* Lead quality assurance activities for all manufactured and marketed products
* Ensure GMP compliance and stable supply through sound decision-making with QA leadership
* Conclude, review, and negotiate Quality Technical Agreements with domestic and overseas CMOs
* Evaluate CMO change controls in collaboration with Regulatory Affairs and SCM to protect supply continuity
* Investigate complaints and deviations, drive root cause analysis, and implement preventive actions with CMOs
* Conduct quality audits and product quality reviews to enhance GMP standards and CMO technical capabilities
Requirements:
* More than 3 years of quality assurance experience in the pharmaceutical industry
Preferred requirements:
* Experience as a quality assurance manager for prescription drugs or equivalent
* Prior experience working at a pharmaceutical manufacturing plant or at a pharmaceutical research institute
- 応募資格
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- 必須
- More than 3 years of quality assurance experience in the pharmaceutical industry
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY8,000,000.00 - JPY11,000,000.00 per annum
- 休日休暇
- weekends off, public holidays, paid holidays
