Project-Doc. Control & Project Supporter-Beijing

Job description

职责 Responsibility

1Project项目

·  1.1 Technical compliance (50%) 技术合规（50%）
·  1.1.1 Technical documentation & drawing management, Responsible for document and drawing management comply with Sanofi standards, including but not limited to project documents, equipment documents, SOP and GMP records of project department. Department shared folder update and management accordingly
·  部门文档及图纸管理, 遵循Sanofi文档管理政策负责部门文件和图纸管理，包括但不仅限于工程/设备档案管理，部门SOP管理，GMP记录管理等，同时也因此需要负责部门共享文件夹的日常管理及维护
·  1.1.2 Responsible for the PO/PR initiation and follow up for project, contact process tracking
·  在项目执行阶段，负责建立PO/PR, 并且在项目执行过程中进行监督，负责合同签署过程追踪
·  1.2 Documentation (30%) 文件工作（30%）
·  1.2.1 Tracking project documents matrix and provide weekly report, Properly archive documents and drawings within 5 days (on average)
·  按照项目的文件矩阵追踪文件完成情况，提交周报；通常五日内完成文件的归档；
·  1.2.2 Ensure full project team fulfilment of trainings needs
·  确保项目团队满足所需的培训
·  1.3 Other and administration (20%) 其他和行政工作（20%）
·  1.3.1 Manage and tracking department procurement activities (the whole lifecycle from bidding to payment) in accordance with CAPEX and OPEX budget.
·  部门采购活动支持及管理（贯穿整个采购周期从投标直到付款），确保采购活动严格遵循CAPEX和OPEX预算
·  1.3.2 Department admin activity support (training, office supplies, attendance etc.)
·  部门行政事务支持（培训，办公用品及考勤等）

2 Quality System Works质量体系工作：

·  2.1 Able to apply tools, concepts, techniques, knowledge and processes according to LSOPs relating to functional role and consciously use it in routine and some non-routine work independently.
·  能够运用工具、概念、技术、知识和流程，根据LSOPs相关要求，自觉的独立完成常规和非常规的工作。
·  2.2 Ensure compliance with cGXP & SOPs at all times when performing and recording of routine work.
·  确保所有活动符合cGXP & SOPs
·  2.3 Identify and report all deviations in routine work immediately to supervisor / manager. Implement immediate action to control the deviation.
·  在日常工作中识别偏差并报告立即向主管/经理，立即采取行动控制偏差；
·  2.4 Assist in deviation investigation and implement CAPA.
·  协助偏差调查和实施CAPA
·  2.5 Participate in Level 1 Self Audit within function.
·  参与L1内部审计
·  2.6 Review completed project record. Participate in the development and update of project record, checklists, LSOPs and qualification protocols.
·  审查项目记录完成情况。参与项目的编写和更新项目记录，清单，LSOPs和验证文件
·  2.7 Execute any other works not mention before come from Project head.
·  执行上级安排的其他未提及的工作

3 HSE 健康安全环境

·  3.1 Sanofi (Beijing) Pharmaceutical Co., Ltd. Energy Policy: \'Quality as the top priority, through technical, behavioral, human consciousness, continuously reduce the rate of energy consumption in product value, benefit the users, and promote company development\'. Good awareness of energy conservation is required, participate in energy saving actions, and assist in the continuous development of the energy management system.
·  赛诺菲（北京）制药有限公司能源方针：“以药品质量为第一要务，通过技术手段，行为规范，人为意识，不断降低产品价值中的能耗比重，造福广大用户，促进企业发展”要求每位员工具有良好的节能意识，积极的节能行动，协助能源管理体系的持续开展
·  3.2 To ensure that department activities according to the approved HSE responsibilities system to obtain the required HSE conditions
·  确保部门活动遵循批准的HSE责任达到相应的HSE条件

任职要求 Requirement

1 Education

·  University Degree Pharmacist, or related specialty

2 Technical skill & Competencies Language

·  Document management
·  Completes, and/or performs review / double check of documents / checklist
·  Able to propose improvement, prepare / draft LSOPs, checklists
·  Finance knowledge to support project cost/purchase tracking
·  English Medium
·  Good communication and owner ship

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.