摘要
About the Role
主要职责：
- 执行与放射配体疗法（RLT）产品制造相关的所有活动。职责包括操作和维护A级隔离器，专注于关键绩效指标（KPI）目标，并确保遵守所有州级、联邦及诺华的辐射安全指南。
- 负责按时成功完成所需的培训课程，包括必要的标准操作程序（SOP）、无菌技术、更衣资格认证以及与该岗位相关的其他培训（包括健康、安全与环境 HSE）。
- 支持与生产准备相关的所有技术方面，包括手动清洁工作单元和使用过氧化氢蒸汽对隔离器进行灭菌。
- 根据要求进行常规和动态的环境监测。
- 推动“勇于发声”的文化，确保所有cGMP合规活动得到遵守。
- 准备相关文件和记录，如批记录、运输文件和培训材料。
- 鉴于产品的时间敏感性，该职位可能需要临时加班以确保流程的连续性和完成。
- 灵活穿戴洁净室服装和个人防护装备（PPE）
- 近距离视力相当于20/20，且无色觉障碍。允许使用矫正镜片以达到所需的视力水平。
- 在受限区域内禁止使用化妆品、佩戴首饰、涂指甲油、使用香水/古龙水及其他可能成为微生物来源的物品。
- 搬运或提举最多达35磅（约16公斤）的物品。
- 根据需要，可能会分配其他职责。
关键绩效指标：
• 批记录执行“第一次即正确”，无重复偏差。
• 遵守出勤指南及所有与安全相关的操作程序。
• 与A级隔离器或B/C级区域相关的审计中无重大或关键性发现。
• 生产过程符合所有良好文件规范（GDP）和良好生产规范（GMP）原则。
• 无菌/洁净室行为符合GMP指南要求。
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
