Manufacturing and Supply
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Team leadership: Lead a team of qualification and validation professionals, providing guidance, direction, and support to ensure effective execution of their responsibilities.
cGMP要求 Qualification and validation strategy: Develop and implement qualification and validation strategies, policies and procedures in alignment with regulatory requirements, industry best practice, and Sanofi standards.
Maintain overview of state of validation at site and establish the project prioritization across site.
Establish and manage the respective validation plans by aligning, coordinating and supervising the prioritization of activities against the business needs. Reviews risk assessments for validation. 审阅验证风险评估 Set local procedures & templates for respective validation documentation and validation master plan, provide guidance to facility impact and component criticality assessments. &模板，为物料风险性评估和设施影响评估提供指导 Responsible, through the validation experts and SME, to translate the critical process parameters and the process control strategy into a focused validation plan for process validation.
Develop the strategy for life cycle verification (CPV) and annual monitoring, ensure the plan in place. Ensures all critical process parameters and quality attributes are monitored or analyzed.
Maintain all validation activities in an inspection ready status ahead of any internal or external audits.
Ensure a proper prioritization approach for High-level product assessments, product validation, and compliance activities.
Support and participate in improvement of products and product launch and technical study. Be a senior adviser in case difficult validation challenges at site.
Establish and monitor validation KPIs
Keep on developing the validation SOPs according the global quality directives/standard/guidance/cGMP and other local requirements together with other department. cGMP以及地方要求进行差距分析及升级，并配合其他部门对标准操作规程进行不断改进升级； Support related departments to execute the internal audits program, external audit.
Follow up validation related CAPA making sure they are completed on time.
Quality Department HSE Responsibilities质量部HSE职责 Responsible for following the company’s HSE policy, and integrated all requires into daily job. 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 planHSE工作纳入工作计划中。Organize the implementation of HSE management target plan of this department, implement HSE rules and regulations, HSE operation procedures and HSE technical action plan.HSE管理目标计划，落实HSE规章制度、HSE操作规程和HSE技术措施计划。Regularly carry out to identify HSE potential hazards and develop action plan and finish on time.HSE隐患排查治理工作，制定整改计划并按时完成隐患整改。Timely working out of employee opinions.HSE教育与考核工作；及时处理员工提出的意见。Actively cooperate with HSE management to prevent accidents happens.HSE管理工作，防止各类事故的发生。Regularly carry out +QDCI meetings at all levels considering HSE8 requirements. Feedback HSE issues in a timely and accurate manner, and actively implement remediation.+QDCI会议，结合HSE8要求，及时、正确填写和反馈各类HSE问题，并积极落实整改。Participate in the investigation for accidents, analyze the root causes of accidents from the quality management perspective, and related CAPA.
Responsible for design annual department PASS plan, and ensure implementation as planned. PASS计划，并按进度组织实施。