药明生物
DP5目检团队负责人
岗位职责
JOB RESPONSIBILITY
管理车间的所有生产活动。 Manage all of the manufacture activities.
熟悉预充式注射器半自动灯检机及全自动灯检机等制剂生产设备的工作原理 Familiar with the working principle of manufacturing equipment such as semi-automatic visual inspection machine and automatic visual inspection machine for pre-filled syringe.
熟悉人工目检、半自动目检以及全自动灯检的相关标准操作规程 Familiar with the standard operating procedure of MVI, SAVI and AVI.
管理车间设备清洁。 Manage all of the equipment cleaning in facility.
参与/管理工序文件升版及维护。 Participate in and/or manage the revision and maintenance of process documentation.
管理车间的验证活动。 Manage the validation activities in facility.
熟悉制剂验证的基本概念，法规指南要求。 Familiar with the basic validation concept and the requirements of regulation and guidance.
熟悉cGMP法规要求。 Familiar with the requirements of cGMP regulation.
根据需要领导团队合规审计和巡检，并与所有员工一起倡导公司合规&EHS精神 Lead team compliance audits and inspections as needed, and actively promote the company’s compliance and EHS culture in collaboration with all employees.
根据需要积极参与风险评估和团队偏差调查，保证团队生产质量。 Actively participate in risk assessments and team deviation investigations as required, to ensure and maintain production quality.
任职要求
教育程度/经验Education background/ Experience 专科及以上，生物，化学工程，食品，制药，机械工程/自动化相关专业 Specialty or above, biology, chemical engineering, food, pharmaceutical, mechanical engineering/automation related specialty 专科：8年以上专业领域经验 Specialty: Over 8 years of experience in a specialty area 本科：5年以上专业领域经验 Undergraduate: Over 5 years of experience in a specialty area 硕士：3年以上专业领域经验 Master: Over 3 years of experience in a specialty area 其他要求Other requirements 精通制剂生产流程及岗位生产操作步骤；精通一类及以上设备或GMP生产流程；独立完成SOP/MBR的撰写; 掌握技术转移放大风险点及流程；至少认证为SME（Layer 1）； Possesses strong expertise in GMP pharmaceutical manufacturing, with hands-on experience in equipment operation, documentation development (SOPs/MBRs), and technology transfer scale-up, recognized as a certified Layer 1 SME at least.
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