岗位描述
一. 最低任职要求Minimum Requirement 教育程度/经验Education background/ Experience 微生物学，生命科学, 制药，生物工程或相关专业本科以上学历，具有上游GMP生产操作的相关知识或经验 Degree in microbiology, life sciences, pharmacy, bioengineering, or related fields, with knowledge or experience in upstream GMP production operations. 二. 其他要求（比如工作时间或特殊技能等）Other requirements (e.g.: working time, special skills)1.优秀的沟通能力，良好的中英文听、说、读、写能力 Excellent communication skills, good listening, writing, speaking and reading in English and Chinese.2. 能接受一定程度的双休日或者夜间加班 Can work during weekend or night to some extent.三. 工作职责JOB RESPONSIBILITY1. 参与项目从技术转移，到微生物发酵、细胞培养、澄清过滤的生产活动，确保批生产活动符合 cGMP 的要求 Participates in projects from tech transfer to microbial fermentation, cell culture, clarification manufacturing activities to ensure compliant to cGMP requirements.2. 负责起草GMP相关文件，包括但不限于SOP/MBR/URS/FAT/SAT/IOPQ Responsible for drafting GMP-related documents, including but not limited to SOP/MBR/URS/FAT/SAT/IOPQ.3. 参与偏差调查工作、领导或参与变更实行及纠正和预防措施的执行。配合上级完成偏差，变更和 CAPA 文件的撰写 Participate in deviation investigation. Lead or participate in the execution of Change Control or CAPA. Complete the deviation investigation report, change control record and CAPA with supervisor.4. 定期检查生产设备和设施的维护，必要时与工程或其他部门协作，确保生产活动的顺利进行 On a regular basis, review manufacture equipment and facility maintenance, co-ordinate with engineering or other department to ensure smooth manufacture activity when necessary5. 按时完成个人的 cGMP 培训任务, 保证自己有资质执行所需操作。必要时配合部门对其他有需求的员工进行相关培训 Complete the cGMP training on time and make sure that the personnel have been qualified before GMP operation. Qualify other operators when necessary.6. 负责组内及部门的日常行政管理事务 Be responsible for the daily administrative affairs of the group and department7.熟悉微生物上游发酵生产，能熟练操作不锈钢或者一次性发酵罐，管式离心机，深层过滤，连续流离心机等； Have hands-on experience in fermentation, hands on experience with SUF, SSF, tube centrifuge, disc centrifuge (GEA), depth filtration et al;8.熟悉生物制品相关法规，和GMP体系，善于沟通和合作，逻辑思维能力强，能撰写各种技术分析报告； Familiar with regulations related to biological products and the GMP system, good at communication and cooperation, strong logical thinking ability, and capable of writing various technical analysis reports9. 完成上级交待的其他相关任务 Finish other related tasks assigned by upper management.