生产经理(J10106)

该职位来源于猎聘 职责描述： ***According to the company's needs, it is required to work at Frontage Laboratories in the United States for 6 to 12 months.根据公司安排，需要在美国方达工作6-12个月。Lead and Train CTM manufacturing staff for GMP operations including manufacturing, equipment assembly and operation, managing raw material etc. 领导并培训CTM生产人员开展 GMP 操作，包括生产、设备组装与操作、原材料管理等工作。Possess extensive experience in GMP production of sterile preparations, including but not limited to injections, lyophilized injections, and eye drops (BFS), etc. 具有丰富的无菌制剂GMP生产经验，包括但不限于注射液、粉针剂和滴眼液（BFS）等。Lead media fills for aseptic fill projects. 主导无菌灌装项目的培养基模拟灌装。Document and review all manufacturing and maintenance activities and events in logbooks, electronic quality systems such as ZenQMS following SOPs and Good Documentation practices. 遵循标准操作规程（SOPs）和良好文档规范，在日志以及 ZenQMS 等电子质量系统中记录并审核所有生产及维护活动与事件。Assist in equipment set-up, operation, maintenance, cleaning as required for projects. 根据项目需求，协助进行设备的安装、操作、维护和清洁工作。Assist in environmental monitoring of manufacturing areas per applicable SOPs. 依据相关标准操作规程，协助对生产区域进行环境监测。Assist with manufacturing area maintenance such area monitoring and qualification, purchase of equipment and room cleaning supplies. 协助开展生产区域的维护工作，如区域监测与确认、设备及车间清洁用品的采购等。Interface with product development team for transfer of knowledge and processes for CTM Batch ManufacturingLead and Train CTM manufacturing staff for GMP operations including manufacturing, equipment assembly and operation, managing raw material etc. 领导并培训CTM生产人员开展 GMP 操作，包括生产、设备组装与操作、原材料管理等工作。Possess extensive experience in GMP production of sterile preparations, including but not limited to injections, lyophilized injections, and eye drops (BFS), etc. 具有丰富的无菌制剂GMP生产经验，包括但不限于注射液、粉针剂和滴眼液（BFS）等。Lead media fills for aseptic fill projects. 主导无菌灌装项目的培养基模拟灌装。Document and review all manufacturing and maintenance activities and events in logbooks, electronic quality systems such as ZenQMS following SOPs and Good Documentation practices. 遵循标准操作规程（SOPs）和良好文档规范，在日志以及 ZenQMS 等电子质量系统中记录并审核所有生产及维护活动与事件。Assist in equipment set-up, operation, maintenance, cleaning as required for projects. 根据项目需求，协助进行设备的安装、操作、维护和清洁工作。Assist in environmental monitoring of manufacturing areas per applicable SOPs. 依据相关标准操作规程，协助对生产区域进行环境监测。Assist with manufacturing area maintenance such area monitoring and qualification, purchase of equipment and room cleaning supplies. 协助开展生产区域的维护工作，如区域监测与确认、设备及车间清洁用品的采购等。Interface with product development team for transfer of knowledge and processes for CTM Batch Manufacturing 与产品开发团队对接，推进临床批次生产的技术转移。Manage CTM project related technical activities and communication with project sponsors. 管理与临床CTM项目相关的技术活动，并与项目 Sponsor 保持沟通。Schedule and ensure cleaning and sanitization of the GMP facility including cleanrooms per the SOP. 按照标准操作规程，制定并执行 GMP 设施（包括洁净室）的清洁与消毒计划。Equipment maintenance and facility maintenance and coordination according to the calibration schedule and GMP manufacturing schedule. 根据校准计划和 GMP 生产计划，协调并开展设备维护与设施维护工作。Collaborate with other teams (Analytical, PD and Quality Assurance) to ensure timely project execution. 与其他团队（分析团队、产品开发团队、质量保证团队）协作，确保项目按时执行。Manage CTM production scheduling and forecasting in collaboration with PD and Analytical functions. 与产品开发团队和分析团队协作，管理临床样品的生产计划与预测。Assist with drafting of technically sound manufacturing batch records, SOPs, protocols, and specifications as required, while adhering to good documentation practices (GDP). 按照良好文档规范（GDP），协助起草技术合规的生产批记录、标准操作规程、方案及质量标准等文件（如需）。Lead deviation investigations and support on-time closure of deviations and CAPAs 主导偏差调查，支持偏差及纠正预防措施（CAPAs）的按时关闭。Ensure overall inspection readiness for area of focus and participate as an SME in client audits and regulatory agency inspections. 确保所负责区域随时做好检查准备，并作为领域专家参与客户审计及监管机构检查。Managing the review of production and quality control records and the review and approval of Change Controls, CAPAs and other GMP related documents. 负责审核生产及质量控制记录，以及审核和批准变更控制、纠正预防措施（CAPAs）及其他 GMP 相关文件。Follow company polices and conduct work according to appropriate Frontage SOPs and comply with cGMP guidelines. 遵守公司政策，按照方达（Frontage）相关标准操作规程开展工作，并符合现行药品生产质量管理规范（cGMP）指南要求。 任职要求：Bachelor's degree or above in medicine, pharmacy, biology or related majors 医学、药学、生物学或相关专业本科及以上学历 2. least 8 years of working experience in the pharmaceutical industry, with more than 3 years of workshop production management experience. 8年及以上医药行业工作经验，3年以上车间生产管理经验Working experience in leading a team and working in cross -function team projects. 具备带领团队工作的经验，以及参与跨部门团队项目的经验。Fluent in both spoken and written English, with excellent communication skills in English. 英语听说读写流利，具备出色的英语沟通能力Good document drafting ability 良好的文件起草能力