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| 部署・役職名 | Quality Specialist － 横浜市鶴見区 |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Good Manufacturing Practices （GMP）: －Ensure products meet the highest standards of quality and regulatory compliance. －Maintain and improve Quality Management Systems （QMS）, conduct internal and external audits and support regulatory inspections. Pharmaceutical Quality Systems in Manufacturing: －Responsible for updating and managing key manufacturing－associated documents in PQS. －Review and approve deviations, change controls and Corrective and Preventative Actions （CAPAs） Regulatory Compliance ＆ Safety: －Ensure compliance with Japanese PMDA and MHLW regulations. －Maintain and enforce radiation safety standards in accordance with Japanese Nuclear Regulation Authority （NRA） guidelines. －Lead audits and inspections from regulatory bodies, implementing corrective actions as needed. Quality Assurance ＆ Control: －Oversee Quality Control （QC） and Quality Assurance （QA） processes, ensuring all products meet safety and efficacy standards. －Maintain accurate documentation, including batch records, SOPs, and deviation reports, in compliance with Japanese and international GMP. －Collaborate with regulatory and quality teams to investigate and resolve non－conformities. Leadership ＆ Team Management: －Supervise and mentor Japanese and international staff, fostering a culture of safety, quality, and operational excellence. －Conduct training programs on radiation safety, GMP, and operational best practices. －Ensure effective cross－functional collaboration with R＆D, regulatory, and commercial teams. Stakeholder ＆ Business Management: －Support business expansion strategies, including technology upgrades, new product introductions, and site improvements. －Manage budgets, cost control measures, and resource allocation to meet operational and financial targets. |
| 応募資格 |
【必須（MUST）】 － Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, Nuclear Medicine, Engineering, or a related field.－ Experience in GMP manufacturing. － In－depth knowledge of PMDA, MHLW, and GMP regulations in Japan. － Fluency in Japanese and English 【歓迎（WANT）】 － Experience managing regulatory audits and compliance with radiation safety protocols.－Certification in Radiation Safety or Nuclear Pharmacy （e.g., RSO training, JNMT certification）. －Experience with Lean Manufacturing, Six Sigma, or Kaizen methodologies. |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2025/09/02 |
| 求人番号 | 5359648 |
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です