必备条件:
1 英语完全可作为工作语言
2 GMP体系下工作经验
3 熟悉现场QA流程
4 管理经验丰富，擅长人员管理
优先条件:
一线外资药厂
岗位职责:
Main responsibilities职责描述：
Please indicate here the main job responsibilities请列举该职位的主要工作职责。
• Act as the QA PCU Lead to respond to operational QA business for PCU.
作为PCU质量保证团队的负责人负责相关的现场QA质量管理业务。
• Provide quality assurance oversight by performing routine walk-throughs and inspections on production, laboratory, warehouse, engineering deportment and other areas assigned where the business is responsible to ensure that all aspects of operations comply with cGMP legal and regulatory requirements as well as global guidelines
通过日常现场巡视及检查的方式对生产，实验室，库房，工程以及其它区域进行监督，保证所有相关操作符合cGMP、注册法规以及总部文件要求
• Ensure all batch records are reviewed, and when needs, ready for release as required, on behalf of site quality responsible.
确保批记录被审核，且需要时，可代表工厂质量负责人按照要求放行。
• Ensure that all manufacturing/packaging activities comply with the validated processes and the relevant sops and cGMPs
确保所有生产、包装活动符合工艺验证以及相关的SOP和GMP要求。
• Establish procedures and ensure continuous improvement of the PCU quality oversight and GMP documentation.
建立流程并持续改进关于PCU质量运营监督的设计和GMP相关的支持文件。
• Manage the PCU deviation and related customer complaint, corrective and preventative actions (CAPA), out of specification (OOS) handling, and monitor the CAPAs to prevent the recurrence of the not compliance incidents; demonstrate a high level of independent judgment and discretion in the timely identification, investigation and resolution of deviations potentially impacting the quality of products and processes; providing support and advice during cross functional investigations and when required, devise sampling procedures and directions for recording and reporting quality data. As quality representative, approve deviation and lab investigation, to ensure the process handling meet the requirement of regulatory and Sanofi procedure.
有效管理PCU偏差，纠正预防措施和OOS处理，并监控CAPA的落实以预防不符合事件的重现；需在工作中展现高度独立的、及时的判断决断能力；以及理清偏差对产品及工艺影响的能力； 如需要，在跨部门调查中提供支持和建议如提出取样方案，调查方向以及汇报相关质量数据。作为质量代表批准偏差及实验室调查，确保整个过程符合法规及总部要求。
• Support CAPA implementation and review CAPA effectiveness, approve the extension requests of CAPA in systems.
支持CAPA执行和回顾CAPA效果，作为质量代表批准系统中CAPA的延期请求。
• Ensure the plan in place. ensures all critical process parameters and quality attributes are monitored or analyzed.
确保监控和分析所有的关键工艺参数和关键质量特性。
• Support and participate project or improvement of products and product launch and technical study. Ensure a proper prioritization approach for high-level product assessments, product validation, compliance activities
支持和参与项目或产品的改善行动，产品转移和技术研究，对验证进行建议。确保产品质量风险评估、工艺验证和合规行动被优先考虑。
• Establish procedures and ensure continuous improvement of the operational quality oversight and GMP documentation.
建立流程并持续改进关于质量运营监督的设计和GMP相关的支持文件。
• Participate inspection, including the supplier inspection.
参与审计应对包括供应商审计。
• Establish and assure a continuous GMP training to APU to maintain a high level of GMP awareness.
建立并持续开展GMP培训以维护APU员工高水准的GMP意识。
• Act as the final evaluator of change quality to ensure changes are properly evaluated
作为变更质量最终评估人评估确保变更得到正确的评估。
• Develop people via training and coaching to enable them qualified for QA PCU work. Training curriculum up to dat. Ensure associates trained according to the training curriculum.
发展人员，使其能符合QA PCU工作要求。安装计划的要求实施培训，并保证培训及时更新。
• Perform people performance management. Make individual develop plan with personnel within team and build up technical ladder.
进行人员绩效管理。制定团队的个人发展计划，建立人才梯队。
• Approval of relevant documents on behalf of the QA Manager when the QA Manager is absent.
当QA经理缺席时代表QA经理批准相关文件
• Any other specific responsibility appointed by the senior management.
其他未尽职责，遵照上一级管理团队的要求执行。
• HSE responsibilities
HSE 职责
• Responsible for implementing HSE requirements and implementing the measures of HSE to each specific link.
负责贯彻公司 HSE 的有关规定，把公司 HSE 制度的措施贯彻到每个具体环节。
• Incorporate HSE work into the work plan.
将 HSE 工作纳入工作计划中。
• Regularly carry out HSE hidden dangers investigation and management work in this department, set up rectification plans and complete rectification of hidden dangers on time.
定期开展本部门 HSE 隐患排查治理工作，制定整改计划并按时完成隐患整改。
• Actively cooperate with HSE management to prevent various types of accidents.
积极配合 HSE 管理工作，防止各类事故的发生。
• Emerge responsibilities
能源职责
• 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
• Support the initiation, approval and implementation of energy-saving projects
支持节能项目的发起，批准，实施
• According the energy-saving plan, promote the implementation of energy-saving projects
根据节能方案，推进节能项目实施
• Participate in internal and external audit of energy management system
任职要求:
• Experience:
工作经验: with minimum 10 years’ experience in quality control and /or quality assurance, 3 years of which in management position. 至少5年QC或QA工作经验，3年以上管理经验。
• Soft skill:
通用技能: Problem solving and good communication良好的沟通及问题解决能力
• Technical skill:
专业技能: Must be a committed "quality" professional with knowledge of regulated quality systems within the pharmaceutical or related industry. 必须具备制药或相关行业的质量体系的“质量”专业知识经验。
• Education:
教育背景: At least a bachelor degree in pharmacy or chemistry or biology disciplines至少药学或化学或生物学或相关专业大学本科学历
• Languages:
语言要求: Good English verbal & written communications.
英语口语和书写熟练