研发QA专家

该职位来源于猎聘 汇报给抗体QA负责人 负责细胞建库产品生产现场的监督工作，确保生产过程的操作记录等符合GMP法规和文件要求。 Responsible for the supervision of the production site of cell banking products, ensuring that the operation records of the production process comply with GMP regulations and documentation requirements. 审核项目的工艺规程、设备工序操作规程、批生产记录，及相关方案、报告，确保实际操作有效执行。 Review the project's process procedures, equipment process operating procedures, batch production records, and related plans and reports to ensure effective implementation of actual operations. 负责细胞建库生产相关工序的设备电子数据的审核，确保满足工艺要求和数据完整性要求，保证产品质量。 Responsible for the review of electronic data of equipment in cell bank production-related processes to ensure that process requirements and data integrity requirements are met and product quality is guaranteed. 参与GMP区域的定期巡检工作，确保相关区域符合GMP要求。 Participate in regular inspections of GMP areas to ensure that relevant areas meet GMP requirements. 参与细胞建库产品相关偏差的调查活动，确保偏差经过调查，评估并得到及时、正确的处理。 Participate in investigation activities related to cell banking product deviations to ensure deviations are investigated, evaluated and handled promptly and correctly. 审核项目产品放行相关批生产记录，确保产品生产符合工艺参数及文件要求。 Review the batch production records related to the release of project products to ensure that product production complies with process parameters and documentation requirements. 负责研发阶段的质量事件管理（含QMS系统流程），包括但不限于：编号发放、参与调查、追踪行动项完成等，确保质量事件经过调查评估，能够得到及时、正确的处理。 Responsible for the quality incident management (including QMS system process) in the R&D stage, including but not limited to: number issuance, participation in investigation, tracking the completion of action items, etc., to ensure that quality incidents can be handled promptly and correctly after investigation and evaluation. 执行研发实验室现场检查程序，及时将发现的问题反馈到对应部门，并追踪完成情况。 Perform on-site inspection procedures in R&D laboratories, promptly report any issues found to the corresponding departments, and track completion status. 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。 Review relevant plans, data, reports, etc. during the R&D phase, and promptly feedback the review results to relevant personnel. 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. 负责研发阶段客户投诉管理，包括参与PAD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 PAD complaint investigation, complaint registration and filing, and complaint process optimization. 负责研发阶段审计管理，包括参与PAD外部审计、审计材料登记归档、审计流程优化等工作。 Responsible for audit management during the R&D phase, including participation in PAD external audits, audit material registration and filing, and audit process optimization. 负责研发阶段产品（毒理批等）物料管理，包括物料质量标识的发放登记、物料管理等工作。 Responsible for the material management of products (toxicology batches, etc.) during the R&D stage, including the issuance and registration of material quality labels, material management, etc. 负责研发阶段QA相关规程文件的起草、审核、修订工作。 Responsible for the drafting, review and revision of QA related procedural documents during the R&D stage. 负责研发阶段产品（毒理批等）质量状态标识的发放与处理，确保产品质量状态标识与产品质量状态一致。 Responsible for the issuance and processing of quality status labels of products (toxicology batches, etc.) during the R&D stage, ensuring that the product quality status labels are consistent with the product quality status. 负责研发阶段产品（毒理批等）的放行前确认，包括不限于生产记录、检验报告、变更控制、质量事件等，确保符合研发放行要求，保证研发产品质量。 Responsible for the pre-release confirmation of R&D products (toxicology batches, etc.), including but not limited to production records, inspection reports, change control, quality events, etc., to ensure compliance with R&D release requirements and to ensure the quality of R&D products. 参与研发变更（含QMS系统流程）、研发内部质量审计、研发文件&培训&档案管理（含DMS/TMS系统）、研发服务商管理、研发CAPA管理（含QMS系统流程）等。 Participate in R&D changes (including QMS system processes), R&D internal quality audits, R&D document, training and file management (including DMS/TMS systems), R&D service provider management, R&D CAPA management (including QMS system processes), etc. 支持项目推进过程中的相关问题的解决，以及和客户的沟通。 Support the resolution of related issues during the project advancement and communication with customers. 完成上司或领导安排的其它工作。 Complete other tasks assigned by superiors or leaders. 教育背景： Education background: 制药、生物制药、制药工程、生物、应用化学、化学/药物分析或相关专业本科学历或以上。 Bachelor's degree or above in pharmaceuticals, biopharmaceuticals, pharmaceutical engineering, biology, applied chemistry, chemical/pharmaceutical analysis, or related fields. 工作经验： Work experience: （GxP work experience is required for GxP related activities） 制药行业3年或以上QA经验。 3 years or more of QA experience in the pharmaceutical industry. 能力与技能： Ability and skills: 熟悉各国（ICH，NMPA，FDA，EU）法规条款；熟悉研发质量保证体系的建立及持续改进；良好的组织、沟通、协调和管理能力；良好的英语听说读写能力。 Familiar with regulatory provisions of various countries (ICH, NMPA, FDA, EU)

• Familiar with the establishment and continuous improvement of the R&D quality assurance system
• Good organizational, communication, coordination, and management skills
• Good English listening, speaking, reading, and writing skills. 个性与品质：

Behavior And Quality

工作责任心强；严谨负责、踏实、敬业；具备良好的沟通协调能力，以及良好的学习能力和抗压能力。 Strong sense of work responsibility

• Rigorous, responsible, down-to-earth, and dedicated
• Have good communication and coordination skills, as well as good learning and stress resistance abilities.