药明生物
研发QA（专员-高级专员）
岗位职责
/ Responsibilities
负责PD部门的质量保证及质量支持工作，并参与PD质量体系的持续完善与优化。 Responsible for quality assurance and quality support activities within the PD department, and contribute to the continuous refinement and optimization of the PD quality system.
审核分析部门文件管理相关的文件与记录，并参与放行数据及稳定性研究的审核工作。 Review documents and records related to document management within the Analytical Department, and participate in the review of release data and stability study results.
起草和审核QA及PD部门相关文件，包括但不限于SOP、Memo和UE，确保内容准确、规范并符合质量要求。 Draft and review QA and PD-related documents—including but not limited to SOPs, memos, and UEs—ensuring accuracy, consistency, and compliance with quality standards.
监督和协调现场检查及内部自检工作，跟踪CAPA落实情况，并参与及支持官方核查和客户审计。 Supervise and coordinate on-site inspections and internal audits, monitor the implementation of CAPA, and participate in and support regulatory inspections and customer audits.
组织开展新员工培训，并实施质量改进项目及专项质量培训，提升整体质量管理水平。 Organize and deliver onboarding training for new employees, and implement quality improvement initiatives and specialized training programs to enhance overall quality performance.
确保QA文档管理及档案管理工作依照相关要求顺利开展，维持文件的完整性、可追溯性和规范性。 Ensure the effective execution of QA document control and archive management processes, maintaining completeness, traceability, and compliance of documentation.
参与小试、中试、制剂研发和分析部门的日常沟通与协调工作，并协助处理及调查偏差和异常事件。 Participate in routine communication and coordination with early development, pilot-scale, formulation development, and analytical teams, and assist in the handling and investigation of deviations and unexpected events.
积极参与部门及跨部门的流程优化与持续改进工作，推动质量管理和运营效率的提升。 Actively participate in departmental and cross‑functional process optimization and continuous improvement initiatives to enhance quality management and operational efficiency.
任职要求
/ Qualifications
本科及以上学历，具有大分子药物研发经验者优先 Bachelor’s degree or above; experience in large‑molecule biologics development is preferred.
熟悉大分子研发相关法规、指南及行业规范 Familiar with regulations, technical guidelines, and industry standards for biologics development.
良好的英语听说能力，能够进行基本专业交流 Strong English listening and speaking skills, capable of routine professional communication.
良好的沟通协作、执行力与问题解决能力 Strong communication, teamwork, execution, and problem‑solving abilities.
具备责任心、学习能力强，可适应快节奏环境 High sense of responsibility, fast learning ability, and adaptability to a fast‑paced R&D environment.
认同公司的核心价值观，能够融入并践行公司的文化。 Demonstrate alignment with the company’s core values and actively embody and integrate the company culture in daily work.
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