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 Manufacturing
- 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 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