无菌项目QA(J24663)

负责确保与GMP活动相关的标准、操作指南、测试方法、管理程序和其他的程序在活动实施前可用 Be responsible for ensuring specifications, working instructions, test methods, process management and other procedures associated with GMP operation are effective before being used. 负责参与确认、验证活动、以及清洗确认/验证，确保确认和验证活动符合VMP和既定流程的要求 Be responsible for participate qualification, validation activities, including cleaning verification/validation, and ensuring that appropriate qualification and validations are performed according to VMP and defined procedures. 负责执行生产现场QA检查，与区域管理积极沟通，督促持续改进 Conduct QA on-site inspection, actively communicate with regional management to facilitate continuous improvement. 负责参与审计 Responsible for participating audit. 负责确保原材料、包装材料、中间产品、和产品，按照规定的流程和标准进行批准或拒收，签发质量证明、TSE/BSE声明（如需要） Be responsible for ensuring that raw materials, packaging materials and intermediate, and product are approved or rejected according to defined procedure or specification, issue Quality Certificate, TSE/BSE statement (if required). 参与不合格品处理流程 Participate investigation of handing procedure for non-conforming. 负责确保药品在其有效期内，其储存、发货、运输、召回和退货的处理，均能符合既定的程序 Be responsible for ensuring medicinal products are stored, shipped, transported, recall and return handling in compliance with defined procedure throughout their shelf life. 确保客户质量协议的执行，参与项目管理，满足客户期望 Ensure client Quality Agreement execution, participate project management, satisfy client expectation. 负责审核/批准批记录母本、执行批记录、方法验证/转移、项目转移方案/报告、原始数据、CoA、质量证明等，和相关文件符合既定流程的要求 Be responsible for reviewing/approving master batch records, executed batch records, method validation/transfer, project transfer protocol/report, raw date, CoA, quality certification and ensuring related operation and documentation is in compliance with defined procedures. 负责协调偏差调查，确保恰当的纠正预防措施得到实施和记录 Be responsible for coordinating deviation investigations to ensure corrective and preventative actions are carried out and documented. 负责协调变更控制流程，确保任何变更都按照既定流程执行和记录 Be responsible for coordinating change control to ensure any changes are assessed and documented according to defined procedure. 负责协调客户投诉调查，确保恰当的答复客户，以及纠正预防措施的实施和记录 Be responsible for coordinating customer complaints investigation, to ensure appropriate response to customer and corrective and preventative actions are carried out and documented. 负责参与官方、客户和总部的GMP审计，以及相关GMP不符合项的调查、文件记录和交流讨论 Be responsible for taking part in the Authority, client and STA GMP audits, and participate the investigation, documentation and communication of related GMP nonconformity. 负责QA相关文件的起草、修订和审核，以及确保文件保管符合档案管理要求 Be responsible for QA related SOP’s writing, revision and reviewing, make sure documents management comply with archive procedures. 按要求完成岗位相关培训和资质确认 Complete the position related training and qualification. 负责提供GMP/质量保证相关的培训 Responsible for providing GMP/QA related training. 遵守IP和岗位安全操作要求 Comply with IP and post safety operation requirements. 负责与其他部门共同执行周期性质量评审 Responsible for periodical quality management review together with other departments. 完成主管安排的其他工作和任务 Perform other works and tasks assigned from upper management.

药学或化学相关专业，大学以上学历。 University degree or above, major in pharmaceutical or chemistry. 了解制药生产、检测和质量管理，熟悉GMP相关法规。 Knowledge of pharmaceutical manufacturing, testing and quality management, familiar with Good Manufacturing Practices (GMP) related regulations. 良好的普通话/英语的书写/口语交流能力 Good communication skills in Mandarin/English, written/spoken. 熟悉MSOffice等办公软件，会使用趋势分析相关工具 Familiar with MS Office and other office software, can use trend analysis tools. 5年以上药品生产、医药相关行业质量管理工作经验 Minimum 5 years of experience in quality management of medicine production or pharmaceutical related industries. 具有良好的协调沟通能力 Good skills of coordination and communication. 具有良好的问题调查能力和逻辑判断能力 Good skills of problem investigation and logical judgement. 能够与团队协同工作，跨部门合作和自我管理 Good skills of co-working, cross-department collaboration and self-management. 能够跟踪客户质量要求，保证生产进程不受影响，及时放行产品。 Ability to track customer quality requirements, ensure that the manufacturing is not affected, products can be timely released. 具有至少3年以上无菌产品质量保证相关工作经验 Experienced in aseptic product quality assurance at least 3 years 能够在一定的压力下工作，在规定的时间交付工作 Ability to work under pressure and deliver work achievement on time.