QA-无菌方向质量专家(J25188)

1 污染控制策略（CCS）体系建立与管理 Maintain and continuously enhance the site Contamination Control Strategy -基于EU GMP Annex 1、中国GMP及FDA标准，制定公司整体的污染控制策略（CCS），涵盖微生物污染、内毒素/热原及颗粒污染的全方位控制。 Own and continuously improve the company’s overall Contamination Control Strategy (CCS) based on EU GMP Annex 1, China GMP, and FDA standards, covering comprehensive control of microbial contamination, endotoxin/pyrogen, and particulate contamination, etc. -从厂房设计、人员、设备、清洁消毒、人物流、生产工艺、原辅料、监测方法、产品共线等维度建立全面的污染控制体系。Maintain a holistic contamination control system including but not limited to facility design, personnel, equipment, cleaning/sanitization/sterilization, personnel and material flow, manufacturing processes, raw materials, etc. -组织污染控制策略的周期性回顾与持续更新，评估所有关键控制点和监测措施的有效性。Own periodic review and continuous updates of Contamination Control Strategy and evaluate the effectiveness of all critical control points and monitoring measures. 2 无菌工艺支持与技术保障 Act as subject matter expert to provide technical and regulatory inpt into aseptic and sterilization techniques -为无菌生产提供技术和法规支持，解决各生产环节常见的污染问。Provide technical and regulatory support for aseptic techniques when needed -为无菌工艺验证工作提供专业技术和法规支持，包括但不限于培养基模拟灌装、除菌过滤验证、灭菌工艺验证、容器密封性测试（CCIT）、消毒剂效力验证等。Provide technical support based on the most resent regulatory expectation into the aseptic/sterilization process validations including media fill, aseptic filtration, sterilization（VHP, dry heat, steam or hot water autoclaving）, container-closure integrity testing (CCIT), and disinfectant efficacy validation. -参与无菌厂房/车间设计验证、设备选型、技术转移项目URS审核及DQ/FAT/SAT等工作。Participate in aseptic facility/cleanroom design qualification, equipment selection, and technology transfer. Provide technical input into URS review and DQ/FAT/SAT activities. -指导气流模型研究、清洁消毒程序开发、A/B级洁净区人员资质管理等核心无菌技术工作。Provide guidance on aseptic technical activities, including airflow visualization (smoke study) studies, cleaning and disinfection program development, and personnel qualification management in Grade A/B cleanroom areas. 3 质量体系与GMP合规管理 Routine Quality System and GMP Compliance Management -参与搭建和维护无菌质量管理体系，编制和审核相关文件（SOP、批记录、验证方案与报告等）。Participate in the establishment and maintenance of the aseptic quality management system; draft and review relevant documents (SOPs, batch records, validation protocols and reports, etc.). -主导无菌相关偏差、OOS/OOT事件的调，组织根本原因分析与风险评估，制定并跟进纠正预防措施（CAPA）。Lead investigations into aseptic-related deviations and OOS/OOT events; organize root cause analysis and risk assessments; develop and follow up on corrective and preventive actions (CAPA). -制定并持续优化环境监测方案，开展数据统计与趋势分析，及时发现并消除微生物污染隐患。Develop and continuously optimize environmental monitoring programs; perform data statistics and trend analysis to promptly identify and eliminate potential microbial contamination risks. -作为无菌保证技术专家，代表公司应对NMPA、FDA、EMA等监管机构的认证和审计检查。 As a Sterility Assurance Specialist, represent the company in responding to certification and audit inspections conducted by regulatory authorities such as NMPA, FDA, and EMA. 4 培训与团队赋能 Training and Team Empowerment -建立无菌专题相关的培训体系，在微生物控制、无菌操作、污染防控等关键领域提供专业培训与指导。Develop a comprehensive training matrix for aseptic topics, delivering expert-level training and coaching in critical areas including microbial control, aseptic technique, and contamination prevention. -指导各基地/部门SME（领域专家）解决无菌相关技术难题，培养内部无菌保证专业人才。Provide technical guidance to the SMEs in the other functions of the site in aseptic technical issue troubleshooting, and cultivate internal talent pool. 5 法规跟踪与持续改进 Regulatory Monitoring and Continuous Improvement -定期收集和分析国内外法规指南更新，识别最新要求，组织差距分析，确保公司持续合规。Continuously collect and analyze updates to regulatory requirements and guidelines; identify new compliance expectations and conduct gap assessments to maintain sustained compliance. -跟踪无菌保证领域的新技术、新方法，推动隔离器、RABS等先进无菌屏障技术的应用。 Stay abreast of emerging technologies and methods in sterility assurance; promote the implementation of advanced aseptic barrier systems, including isolators and RABS. 招募新员工并确保他们接受适当和充分的培训。向员工提供指导，使他们能够不断提高自己的工作技能。评估并评定团队成员的表现。 Recruit new staffs and ensure that they receive proper and adequate trainings. Coaching staffs so that they can continuously improve their work skills and knowledge. Review and rank group member performance.

本科及以上 Bachelor degree or above 微生物学、药学、制药工程、生物工程、生物学等相关专业 Microbiology, Pharmacy, Pharmaceutical Engineering, Bioengineering, Biology, and other related disciplines. 良好的普通话/英语的书写/口语交流能力 Good writing/communication skill in Mandarin/English 熟悉MSOffice等办公软件，会使用趋势分析相关工具 Familiar with MSOffice and other office software, and tools for trend analysis · 5年以上无菌药品（注射剂、冻干粉针、生物制品等）生产或质量管理经验A minimum of 5 years of experience in manufacturing or quality management of sterile drug products (injections, lyophilized powders, biologics, etc.). ·具有非最终灭菌工艺无菌药品生产或质量管理经验者优先。Candidates with experience in aseptic processing (non-terminal sterilization) of sterile products are preferred. ·有FDA、EMA或欧盟GMP认证检查经验者优先Candidates with experience in FDA, EMA, or EU GMP inspection readiness and audits are preferred. · 有新建无菌产线体系搭建经验者优先 Candidates with experience in establishing quality systems for new aseptic manufacturing lines are preferred. · 精通中国GMP无菌药品附录、EU GMP Annex 1、FDA无菌产品指南等法规要求。 In-depth knowledge of regulatory requirements including the Chinese GMP Annex for Sterile Products, EU GMP Annex 1, and FDA Guidance on Sterile Drug Products Produced by Aseptic Processing. ·熟悉PDA、ISPE等技术指南及行业最新进展。Familiarity with technical guidelines from PDA, ISPE, and the latest industry developments. · 熟练掌握污染控制策略（CCS）、无菌工艺验证、微生物控制、环境监测、洁净室分级等核心无菌技术。 Proficient in core aseptic technologies including Contamination Control Strategy (CCS), aseptic process validation, microbiological control, environmental monitoring, and cleanroom classification. · 精通偏差调查、OOS/OOT处理、CAPA及质量风险管理工具（FMEA等）Expert in deviation investigation, OOS/OOT handling, CAPA, and quality risk management tools (FMEA, HAZOP, etc.). · 具备良好的英语阅读和写作能力，能查阅并理解英文法规及专业文献。 Strong English reading and writing skills, with the ability to review and comprehend English-language regulations and technical literature.