研发QA

该职位来源于猎聘 1负责研发阶段 DMS 系统管理及文件管理，确保文件全生命周期管理的合规性。Responsible for the DMS system and document management during the R&D phase, ensuring compliance throughout the entire lifecycle of document management. 2负责研发阶段 TMS 系统管理及培训管理，确保培训管理、签名备案等的合规性。Responsible for developing the TMS system during the R&D phase and managing training, ensuring compliance with training management, signature filing, and delegation of responsibilities. 3负责研发阶段档案及档案室管理，完善归档文件、记录等符合保存要求，确保档案全生命周期管理的合规性。Responsible for managing research and development phase files and the archive room, improving the filing of documents and records to meet retention requirements, and ensuring compliance throughout the entire lifecycle of the archives. 4负责研发阶段的偏差管理（含 QMS 系统流程），保证偏差经过调查、评估能够得到及时、妥善的处理，确保偏差管理的合规性。Responsible for deviation management during the R&D phase (including QMS system processes), making sure they're looked into, assessed, and dealt with quickly and properly, and keeping deviation management compliant. 5负责研发阶段变更管理（含 QMS 系统流程），保证变更能被有效地评估、批准、执行和记录，确保变更管理的合规性。Responsible for change management during the R&D phase (including QMS system processes), making sure changes can be effectively evaluated, approved, executed, and recorded, ensuring compliance in change management. 6负责研发阶段 CAPA 管理，对识别出来的缺陷，建立有效措施以纠正和预防，确保 CAPA 管理的合规性。Responsible for CAPA management during the R&D phase, setting up effective measures to correct and prevent identified defects, and ensuring CAPA management compliance. 7负责研发阶段服务供应商管理，持续完善管理要求以便保障合格服务商提供的服务能够满足蓬勃生物的业务需求，并确保研发服务供应商管理的合规性。Responsible for managing service providers during the R&D phase, continuously improving management requirements to ensure that qualified service providers can meet ProBio's business needs, and making sure that R&D service provider management stays compliant. 8负责研发阶段 QAA 管理，包括参与审核 QAA 条款、QAA 登记归档、QAA 流程优化等工作。Responsible for QAA management in the R&D stage, including participating in the review of QAA terms, QAA registration and filing, QAA process optimization, etc. 9负责研发阶段客户投诉管理，包括参与投诉调查、投诉登记归档、投诉流程优化等工作。Responsible for customer complaint management during the R&D stage, including participating in complaint investigation, complaint registration and filing, and complaint process optimization. 10审核研发阶段相关方案、数据、报告等，并及时将审核结果反馈给相关人员。完善研发数据与记录的管理要求，确保研发数据可靠性。Review R&D phase-related plans, data, reports, etc., and promptly give feedback on the review results to the relevant personnel. Improve the management requirements for R&D data and records to ensure the reliability of R&D data. 11负责研发阶段的物料管理，包括物料供应商资质要求、物料质量标识管理（如涉及）等，持续完善物料管理的合规性要求。Responsible for material management during the R&D phase, including material supplier qualification requirements, material quality labeling management (if applicable), and continuously improving the compliance requirements for material management. 12负责研发阶段产品（毒理批等）的放行管理，包括不限于制备记录、检验报告和记录、变更控制、研发偏差等内容的确认，确保符合产品放行要求，保证研发产品质量。持续完善产品管理的合规性要求。Responsible for release management of products in the R&D phase (like toxicology batches), including but not limited to verifying preparation records, inspection reports and records, change control, and R&D deviations, to ensure they meet product release requirements and maintain R&D product quality. Continuously improve compliance requirements for product management. 13执行现场检查程序，及时将发现的问题反馈到对应部门，并追踪完成情况。Execute on-site inspection procedures, promptly report any issues found to the corresponding department, and track completion status. 14协助客户及法规机构对研发阶段的体系审计。Assist clients and regulatory agencies with system audits during the R&D phase. 15负责研发体系的内部质量审计（自检）。Responsible for internal quality audits (self-f-inspection) of the R&D system. 16负责研发阶段 QA 相关文件的起草/修订、审核工作。Responsible for drafting/revising and reviewing QA-related documents during the R&D phase. 17负责研发阶段相关业务部门文件的审批。Responsible for reviewing and approving documents from business departments related to the R&D phase. 18负责研发阶段系统/仪器相关验证文件的审批。Responsible for reviewing and approving system/instrument verification documents during the R&D phase.

19完成上司或领导分配的其它工作。Complete other tasks assigned by superiors or leaders.