锦鲤求职岗位描述
Responsibilities:
职责：
1. Responsible for routine quality oversight for DS GMP areas to ensure all GMP activities are executed based on regulations, SOPs and related procedures.
负责对原液GMP生产区域进行日常质量监督，以确保所有GMP活动均根据法规、SOP和相关程序执行。
2. Responsible for review DS manufacturing and testing related documents.
负责原液生产和检验相关文件的审核。
3. Responsible for DS manufacturing batch record review, electronic data batch release and electronic data periodic review.
负责原液生产批记录审核、电子数据批放行审核和电子数据定期审核。
4. Responsible for DS facility, utility, equipment and instrument release.
负责原液生产设施、公用设施、设备和仪器的放行。
5. Involved in GMP related deviation, change control, CAPA and lab investigation work. Participate in handling quality event investigation, risk assessment, complaints, participate in implementation supervision of process control strategy and contamination control strategy.
参与GMP相关偏差、变更控制、纠正预防措施和实验室调查工作。参与处理质量事件的调查、风险评估、投诉，参与工艺控制策略和污染控制策略的实施监督。
6. Participate in improvement activities including but not limited to MBR design, SOP optimization, and quality system continuous improvement.
参与改进活动，包括但不限于主生产记录设计、标准操作规程优化和质量体系的持续改进。
7. Support GMP audits and inspections; Support QA project management.
支持GMP审计和检查；支持 QA 项目管理工作。
8. Complete other tasks assigned by the supervisor/ team leader.
完成主管/团队主管分配的其他任务。
Requirements:
要求：
1. Education background/ Experience: Bachelor degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical, Biological Engineering, or related field.
教育背景/经验：化学、生物化学、生物学、药学、生物工程部或相关领域的学士学位或以上学历。
2. At least 3 years of practical experience in pharmaceutical manufacturing and quality management, including at least1 years of quality management experience.
至少3年药品生产和质量管理实践经验，其中至少1年质量管理经验。
3. Familiar with FDA/China/EU and ICH GMP requirements; Familiar with sterile pharmaceutical production and quality system; Better for knowing ADC DS manufacturing process.
熟悉 FDA/中国/EU和ICH等GMP要求；熟悉无菌药品生产和质量体系；熟悉 ADC DS 生产工艺更优。
4. Good communication and coordination skills; Good office skills; Better for Good English language skill (listening, speaking, reading and writing).
良好的沟通协调能力；良好的办公技能；良好的英语语言能力更优（听、说、读、写）。