锦鲤求职岗位描述
关键职责Key Responsibilities负责 DP 生产区的常规质量监督，以确保所有良好生产规范活动（包括配制、无菌灌装、冻干、目视检查和包装）均根据 SOP 和相关规程执行。Responsible for routine quality oversight for DP manufacturing areas to ensure all GMP activities including formulation, aseptic filling, lyophilization, visual inspection, and packaging are executed in accordance with SOPs and related procedures.负责建立和完善商业化包装质量体系，参与包装过程的验证活动、偏差调查，配合处理与包装过程有关的投诉，负责药品追溯平台的监督管理。Responsible for establishing and improving the commercial packaging quality system, participating in the validation activities and deviation investigation of the packaging process, cooperating in the handling of complaints related to the packaging process, and overseeing the drug traceability platform.负责DP区域现场质量监控。Responsible for on-site quality monitoring in DP areas.负责审查 DP 生产工艺文件，包括但不限于工艺流程图、物料清单、主生产记录，以确保符合法规和公司程序。Responsible for the review of DP manufacturing processes documents including but not limited to PFD, BOM, MBR to ensure the compliance with regulation and company procedures.负责执行审核批记录、电子数据审查。Responsible for batch record and e-data review.负责 DP 生产相关 SOP、QRA等文件审核。Responsible for reviewing DP manufacturing-related SOPs, QRA, etc.支持客户和官方审计和检查。Support client and regulatory audits and inspections.完成直线经理及以上人员分配的其他任务。Complete other tasks assigned by line manager and above.资质Qualifications:相关领域（例如，生物学、化学、药学、工程部）本科或以上学历或同等经验。Bachelor’s degree or above in a relevant field (e.g., Biology, Chemistry, Pharmacy, Engineering) or equivalent experience.3年以上制药行业QA或生产岗位工作经验。At least 3 years of experience in a QA or production role within the pharmaceutical industry.有商业化目检包装产品的生产或质量管理经验，熟悉手工和自动包装线关键控制点，熟悉人工目检和自动目检的流程和过程控制，熟悉药品追溯系统的管理。Have experience in manufacturing or quality management of commercial visual inspection and packaging, be familiar with the critical control points of manual and automatic packaging lines, be familiar with the process and In Process Control of manual and automatic visual inspection, and be familiar with the management of drug traceability system.能够在快节奏、动态的环境中有效工作。Ability to work effectively in a fast-paced, dynamic environment.良好的英语读写能力。Good English reading and writing, great for English speaking.