供应商&物料管理QA
Summary
Quality Assurance role at WuXi Biologics' Wuxi site: manage material and service suppliers (qualification, on-site audits, performance reviews), oversee material release and warehouse GMP operations, and handle equipment release, document approval, and quality events such as deviations, changes, and CAPAs.
1、负责基地供应商管理相关工作：
Responsible for local supplier related work as follows:
• 负责生产所用物料（原辅料，关键性生产耗材，包装材料）供应商（生产商和经销商）、服务商的管理，包括但不限于资格审查，评估，现场审计，定期评估等。
Responsible of management of all suppliers (manufacturer and distributor) of materials (raw materials, excipients, key consumables and packing components) and service providers, including but not limited to qualification, evaluation, on site audit and periodical assessment.
• 负责供应商、外包服务供应商投诉、绩效、变更通知的评估的管理。
Responsible of management of supplier's complaint, performance review, change notification evaluation.
• 负责开展药品上市许可持有人及受托生产产品评估管理工作。
Responsible of performing evaluation management of Marketing Authorization Holder (MAH) and contract manufactured product.
2、负责仓库物料、产品及物料放行相关管理职责：
Responsible for material release related work as follows:
• 负责物料的放行及相关工作；
Release RMM and related work;
• 制定公司异常物料/产品、不合格物料/产品的处理流程，监控不合格物料/产品销毁流程的执行；
Build the handling procedures for abnormal materials/products and rejected materials/products, and monitor the implementation of destruction process for rejected materials/products;
• 负责仓库洁净区、物料与产品接收、贮存、分发等流程及现场的监管，审核批准相关流程文件；
Responsible for the monitoring receipt, storage, distribution process and on-site of materials and products and cleaning area, and reviewing and approving relevant process documents;
• 确保按照项目要求完成物料称量记录的发放、审核及批谱系的出具；
Ensure completing the distribution and review of material weighing records and issuance of batch genealogy according to the production requirements of the project;
3、负责设备相关的管理工作：
Responsible for related equipment management work as follows:
• 参与仓库GMP设备（如冰箱、运输设备、衡器等）放行流程，审核相关验证方案&报告；
Participate in GMP equipment (such as refrigerator, shipping equipment, weighing device, etc.) release process in warehouse and review related validation protocol and report;
• 参与报警策略的制定，审核报警评估，确保充分评估报警对物料/产品质量的影响；
Developing equipment alert strategy and review alert assessment to ensure that the impact of alert on materials/products quality is adequately assessed;
4、其他：
• 文件的审核与批准：如物料/产品/设备/供应商相关流程表单、memo、QRM、PRT等文件；
Review and approval forms/logbooks/memo/QRM/PRT documents related to materials/products/equipment/supplier;
• 质量体系的监管：物料相关的偏差、变更、CAPA等质量事件的审核与批准；
Review and approve deviations, changes, CAPAs and other quality events that related to materials;
• 配合公司进行物料对应区域的自检和审计工作；
Cooperate with the company to carry out self-inspection and audit work related to material management scope;
• 上级领导交代的其他工作。
Deal with other projects/tasks assigned by manager