募集要項
- 募集背景
- A multinational pharmaceutical organisation is looking for a QA Senior Manager. The selected applicant will support quality activities at Contract Manufacturing Organisations (CMO) and API suppliers by providing on time and effective quality oversight.
- 仕事内容
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A multinational pharmaceutical organisation is looking for a QA Senior Manager.Responsibilities:
* Manage a robust support team for GQP Head daily
* Lead periodic internal reviews with stakeholders (GM, Audit, Supply Chain)
* Supervise assigned CMO and API suppliers, aligned with regulations
* Track CMO Quality Metrics, implement improvements
* Address quality issues promptly for Drug Products or APIs
* Support QMS development and compliance
* Assist in regulatory readiness, manage audits, aid in business development
Requirements:
* Bachelor's degree or above in a scientific discipline
* More than 7 years of experience in QA/QC of Pharmaceuticals or Medical Devices
* More than 5 years of related experience in a GMP/GQP environment
* Operational knowledge of pharmaceutical processing and packaging operations
* Expertise in investigations (Lean Six Sigma), Quality Agreements, and CMO management
* Knowledge of technical pharmaceutical processes, risk assessment, and risk management fundamentals/tools
* Understanding of GMP/GQP, QA/QC and regulatory compliance (Japan, US, EU, and other regulatory requirements)
* Skilled in OOS/deviation investigations, Quality Agreements, and CMO management
* Background in drug product sterile pharmaceutical or biologics manufacturing and QC is ideal
* Possess a valid Quality Auditor (ASQ) certification is preferred
* Fluent level written and verbal English (TOEIC 730+)
- 応募資格
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- 必須
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More than 7 years of experience in QA/QC of Pharmaceuticals or Medical Devices
- 歓迎
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More than 5 years of related experience in a GMP/GQP environment
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY13,000,000.00 - JPY15,000,000.00 per annum
- 休日休暇
- weekends off, public holidays, paid holidays