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| 部署・役職名 | Manufacturing Specialist |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Manufacturing Operations ＆ Compliance: －Oversee daily production activities, ensuring compliance with GMP, PMDA （Pharmaceuticals and Medical Devices Agency） regulations, and radiation safety guidelines. －Develop and optimize manufacturing processes for efficiency, quality, and safety. －Ensure proper aseptic techniques and cleanroom procedures are followed in production. －Manage batch record review, deviations, CAPA （Corrective and Preventive Actions）, and continuous improvement initiatives. －Coordinate with Quality Assurance （QA） and Quality Control （QC） to ensure timely product release. Team Leadership ＆ Training: －Lead and develop a growing manufacturing team, ensuring proper training in GMP, radiation safety, and operational procedures. －Foster a culture of safety, compliance, and continuous improvement. －Conduct performance evaluations and provide coaching for staff development. Regulatory ＆ Documentation Management: －Ensure compliance with local and international regulations （PMDA, ICH, PIC/S）. －Support regulatory inspections, audits, and licensing activities. －Maintain accurate and timely documentation, including SOPs, batch records, and deviation reports. Process Improvement ＆ Technology Integration: －Identify opportunities to improve manufacturing efficiency and reduce waste while maintaining product quality. －Implement automation and digitalization initiatives where applicable. －Collaborate with R＆D and engineering teams for process optimization and new product introduction. |
| 応募資格 |
【必須（MUST）】 － Bachelor's or Master’s degree in Pharmacy, Chemistry, Biotechnology, Engineering, or a related field.－ Experience in pharmaceutical or radiopharmaceutical manufacturing in a GMP－regulated environment. － Knowledge of aseptic processing, cleanroom operations, and radiation safety. － Experience with regulatory inspections and audits. － Business－level proficiency in Japanese; English proficiency is a plus. 【歓迎（WANT）】 － GMP certification or training in aseptic processing.－ Lean Manufacturing or Six Sigma certification is a plus. |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2025/09/02 |
| 求人番号 | 5359639 |
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