供应商质量经理/高级经理 - Shanghai
20小时前
工作描述
该职位来源于猎聘 1岗位职责Job responsibility 1.1供应商管理:
Suppliers Management:
负责所有GMP供应商(包括寡核酸和AOC产品的CDMO/物料类/服务类供应商)生命周期管理,如供应商准入前的资质审查、档案的保存与更新、周期性回顾、合格供应商名录的更新与维护等; Responsible for the lifecycle management of all GMP suppliers (including CDMO/material/service suppliers for oligonucleotides and AOC products), such as pre-qualification reviews before supplier approval, supplier profile archive and updates, periodic reviews, and the updating and maintenance of the qualified supplier list. 负责所有GMP供应商审计,含审计计划的制定与执行、审计报告的撰写、整改报告的确认与CAPA状态跟进;
Responsible for all GMP supplier audits, including the development and execution of audit plans, drafting audit reports, confirming corrective action reports, and tracking CAPA status.
12GMP质量体系的维护:
带领团队完成如下工作 Maintenance of GMP
Quality System:
Lead the team to complete the following tasks 质量体系计算机化系统上线,例如:QMS、培训系统; The computerized quality system launch, such as QMS and training system; 根据业务需求起草/修订GMP体系下流程文件,确保符合业务运行,并及时生效; Draft/revise process documents under the GMP system based on business requirements to ensure compliance with business operations and timely effectiveness 维护GMP环境中变更、偏差、CAPA、OOS/OOE等质量体系,确保有效运行; Maintain quality systems such as changes, deviations, CAPA, OOS/OOE in the GMP environment to ensure effective operation; GMP培训:组织GMP新员工基础知识培训、日常培训等符合性管理,沟通协调并制定公司GMP年度培训计划,以及完成情况跟踪汇总; GMP training: Organize GMP new employee basic knowledge training, daily training and other compliance management, communicate and coordinate, and develop the company's GMP annual training plan, as well as track and summarize the completion status
文件管理:
负责按法律法规及公司规定管理GMP受控文件及记录全生命周期;负责GMP档案室管理,文件归档、借阅,确保归档文件完整性及可追溯性。 Document Management:
Responsible for managing GMP controlled documents and records throughout their entire lifecycle in accordance with laws, regulations, and company policies; Responsible for GMP archive management, document archiving and borrowing, ensuring the integrity and traceability of archived documents
自检:
负责完成年度GMP自检的计划、实施、报告、CAPA制定及跟踪关闭;
Self-Inspection:
Responsible for completing the annual GMP self-inspection plan, implementation, reporting, CAPA development, and tracking closure 法规差距分析:定期跟踪识别各官网适用法规,进行差距分析、培训和落地执行;
Regulatory Gap Analysis:
Regularly track and identify applicable regulations from various official websites, conduct gap analysis, training, and implementation 1.
3研发质量管理:
带领团队完成如下工作 R&D
Quality Management:
Lead the team to complete the following tasks 确保研发实验室最基本的数据完整性要求(数据及时性、完整性、可追溯性); Ensure the basic data integrity requirements of the R&D laboratory (data timeliness, completeness, traceability) ; 与研发各部门共同识别防混淆/防出错风险点,形成流程; Collaborate with various R&D departments to identify anti confusion/error risk points and establish a process.
组织团队,进行研发实验室现场合规检查,并跟踪整改;定期对检查发现问题进行分析汇总报告; Organize a team to conduct on-site compliance inspections in the R&D laboratory and track corrective actions; Regularly analyze and summarize problems discovered during inspections, and provide reports.根据业务需求起草/修订研发体系下流程文件,确保符合业务运行,并及时生效; Draft/revise process documents under the R&D system based on business requirements to ensure compliance with business operations and timely effectiveness;
培训:
组织研发新员工基础知识培训、日常培训等符合性管理; Training: Organize compliance management such as basic knowledge training and daily training for new employees in R&D; 归档:负责文件归档、借阅,确保归档文件完整性及可追溯性; Archiving: Responsible for archiving and borrowing documents, ensuring the integrity and traceability of archived files;
自检:
负责完成研发年度自检的计划、实施、报告、CAPA制定及跟踪关闭; Self inspection: Responsible for completing the planning, implementation, reporting, CAPA formulation, and tracking closure of the annual self inspection for research and development;
完成上级领导安排的其他工作。
Complete other tasks assigned by superiors.
2任职资格Qualification 2.1药学、化学、生物等相关专业本科及以上; Bachelor's degree or above in pharmacy, chemistry, biology or related majors; 2.2非常强的供应商管理及供应商审计经验; Strong experience in supplier management and supplier auditing 2.3非常强的GMP合规意识,熟悉国内外GMP法规及相关指南 Strong GMP compliance awareness, familiar with domestic and international GMP regulations and related guidelines 2.410年左右药品研发及生产质量管理经验; About 10 years of experience in drug development and production quality management 2.5熟悉药品生产相关流程; Familiar with the relevant processes of drug production 2.6具备较强的内外部沟通协调能力及团队合作精神; Strong internal and external communication and coordination skills, as well as teamwork spirit; 2.7英文能够做为工作语言 English can be used as a working language.
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