岗位描述
岗位职责 Responsibilities无菌生产操作负责无菌制剂生产相关工作，包括配液、灌装、灯检、贴签等生产操作。Aseptic Manufacturing OperationsPerform aseptic drug product manufacturing activities, including solution preparation, filling, visual inspection, and labeling operations.设备操作与维护负责生产设备的操作、日常维护，并配合设备维修、校验及验证工作，确保设备处于良好运行状态。Equipment Operation & MaintenanceOperate manufacturing equipment, perform routine maintenance, and support equipment repair, calibration, and qualification activities to ensure reliable equipment performance.生产文件管理负责批生产记录、设备使用台账及相关生产文件的填写、审核与管理，确保生产记录真实、完整、可追溯。Production Documentation ManagementComplete, review, and maintain batch production records, equipment logbooks, and related manufacturing documents, ensuring accuracy, completeness, and traceability.洁净区与物料管理负责洁净区的清洁、消毒及生产物料管理，确保生产环境和物料状态符合GMP要求。Cleanroom & Material ManagementPerform cleanroom cleaning and disinfection activities and manage production materials to ensure compliance with GMP requirements.质量与合规管理参与偏差调查、变更管理及相关文件的起草与执行，协助推动问题整改和持续改进工作。Quality & Compliance ManagementParticipate in deviation investigations, change control activities, and related documentation, supporting issue resolution and continuous improvement initiatives.EHS与合规执行严格遵守GMP、EHS、数据完整性及公司相关管理要求，确保生产活动符合质量、安全及合规标准。EHS & Regulatory ComplianceAdhere to GMP, EHS, data integrity, and company compliance requirements to ensure safe, compliant, and high-quality manufacturing operations.任职要求 Qualifications教育背景制药、生物工程、药学等相关专业本科及以上学历；应届硕士毕业生或本科具有3-5年制药生产或工艺相关工作经验。EducationBachelor's degree or above in Pharmaceutical Sciences, Biological Engineering, Pharmacy, or other related disciplines. Fresh Master's graduates are welcome to apply; alternatively, candidates holding a Bachelor's degree with 3 to 5 years of experience in pharmaceutical manufacturing, process development, or related functions are encouraged to apply.专业经验熟悉无菌制剂生产工艺，有无菌药品生产经验者优先。Professional ExperienceFamiliar with aseptic drug product manufacturing processes; experience in sterile pharmaceutical manufacturing is preferred.设备知识熟悉无菌制剂生产设备，了解设备运行原理。Equipment KnowledgeFamiliar with aseptic drug product manufacturing equipment and have a good understanding of equipment operating principles.团队协作能力具备较强的责任心、执行力和团队协作能力，能够适应生产现场工作节奏。Teamwork & ExecutionDemonstrate a strong sense of responsibility, effective execution capability, and excellent teamwork skills in a manufacturing environment.办公软件技能熟练使用Office等常用办公软件，能够完成生产记录、数据整理及相关文件编制工作。Computer SkillsProficient in Microsoft Office and other standard business applications, with the ability to complete production documentation, data management, and related record preparation.综合能力工作认真细致，具备良好的沟通能力、学习能力和问题解决能力，能够在GMP环境下高效开展工作。Core CompetenciesDetail-oriented with strong communication, learning, and problem-solving skills, and capable of working effectively in a GMP-regulated environment.