Ensure any investigations, out-of-specifications, change controls, complaints and any other quality related matter throughout the production from all associated manufacturing sites is closed.
执行审阅并确保在辉瑞的质量管理体系内管理和关闭任何相关偏差
Execute review and ensure any associated deviation is managed and closed within Pfizer’s QMS
确保任何可能需要更改市场授权、生产许可证或GMP许可的变更都按照辉瑞的程序通知管理层
Ensure any changes that may require a variation to marketing authorization, manufacturing license or GMP clearance are notified to management as per Pfizer’s procedures.
协助撰写区域质量审查小组（A-QRT / SQRT）报告并参加会议
Assist in writing Area-Quality Review Team (A-QRT/ SQRT) reports and participate in meetings.通知管理层/Notification to Management
通知SCMOQ中国管理层重大偏差以及影响上市产品的任何问题
Informs SCMOQ China Lead Team of significant deviations, as well as any issues impacting marketed product.
local implementation of actions identified during Area Quality Review Team (AQRT) meetings, e.g. recalls, communication with Regulatory Agency, local corrective/preventive actions
变更控制管理/Change Control management
确保所有变更的启动都包含所有相关信息和附件（如果有）。
Ensure all initiation of changes contains all the relevant information and attached documents(if any).
与发起方协调在QTS中开启事件记录
Coordination with initiator to open occurrence record in QTS.
确保所有变更实施都符合变更流程的要求
Ensure all change implementations meet the requirements of the change process.隔离警报通知（用于国内的非辉瑞仓库接受和储存产品）/Quarantine Alert Notices (where non-Pfizer warehouses are used to receive and store product in the country)
确保及时接收和处理隔离警报通知
Ensure that Quarantine Alert Notices received are processed in a timely manner.承诺追踪/Commitment Tracking
确保按要求完成监管、内部审计和偏差的行动。
Ensure Regulatory, Internal Audit and deviation commitments are completed as required.市场行动/Market Actions
支持本地市场行动团队，并确保有效完成所有必需的行动。
Support local market action team and ensure effective completion of all required actions.产品质量体系/ Product Quality System
确认总部SOP合规性，完成差距分析报告和培训。
Confirm GSOP compliance, completion of gap analysis reports and training.
监控本地质量绩效（指标），并在发现趋势/问题后确定和实施行动，并与所有相关的本地利益相关者分享
Monitor local quality performance (metrics) and identify and implement actions upon discovery of trends/issues and share with all relevant local stakeholders.
评估任何新的或更新的法规要求并实施
Assess any new or updated regulatory requirements and implement.
参与流程和系统的持续改进
Participate in Continuous Improvement for processes and systems.
按照法规要求的时间表完成年度产品报告
Complete the annual product report as per regulation required timeline.
Participate in imported product post-marketing change and communicate with ESOQ and manufacturing site if there are action items(such as CoA/CoC revise etc.) related to quality.产品的处置/ Product Disposition
审阅成品的COA，COC和任何其他相关信息
Review Certificate of Analysis, COC, and any other relevant information, of fully finished products
在系统、应用程序和产品 （SAP）中执行转移
Conduct transactions in Systems, Applications and Products (SAP)
监督退货
Oversight of returned goods.
确保有效和高效的完成本地批次放行
Ensure effective and efficient local batch release.
使用可用数据或获取工厂的支持评估温度偏差，并执行批次处置
Assess temperature excursions, using available data or plant support and provide batch disposition.
与配送仓库质量部门协调定期质量审查会议
Coordinate regular quality review meetings with the distribution warehouse quality unit.
与ESOQ和生产工厂联络，以确定温度偏差的产品的处置。
Liaise with External Supply Operations Quality (ESOQ) and the manufacturing site to determine disposition of product which have experienced a temperature excursion.
确保有系统进行管理
Ensure that a system is in place to manage.
确保按照适当的规范进行检查和维护记录，并根据适当的规范进行评估。
Ensure that records are made and maintained for inspections is undertaken in accordance with and assessed against appropriate specifications.
对退货产品、不合格品执行适当的批次处置
Implement appropriate batch disposal of returned and non-conforming products.
完成新产品的上市前准备和上市放行
Complete pre-launch preparation and market release of new products政府检查和内部审计/Inspections and Internal Audit
负责准备和协调监管机构或辉瑞内部GSP/MAH代理人相关检查
Lead preparation for and co-ordination of GSP/MAH agent related inspections by Regulatory Authorities or Pfizer internal auditors
准备并与SCMOQ经理和相关同事就回复行动计划达成一致，以解决监管检查或辉瑞内部审计期间发现的问题
Prepare and agree with SCMOQ manager and applicable colleagues on responses an action plans to address issues identified during regulatory inspections or Pfizer internal audits.
在确认的时间范围内跟踪已确定行动的实施情况
Track the implementation of the identified actions within agreed timeframes.本地供应商的质量监督/Local Contractor Quality Oversight
确保对本地供应商（物流服务提供商、重新包装商）进行有效的质量监督
Ensure effective quality oversight of local contractors (Logistic Service Providers, re-packers)
确保维护质量协议并反映当前要求
Ensure quality agreements are maintained and reflect current requirements.
审阅质量绩效并商定行动计划以确保持续改进
Review quality performance and agree action plans to ensure continuous improvement
将关键和主要的政府审计缺陷和RQA审计结果传达给SCMOQ中国管理层，并为CAPA计划提供意见
Communicate critical and major regulatory inspection observations and RQA audit findings to SCMOQ China Lead Team and provide input into CAPA plans.
为本地供应商提供高质量的尽职调查，并确保及时处理和关闭 CAPA
Provide Quality Due Diligence for local contractors and ensure CAPAs can be addressed and closed in a timely manner.产品质量投诉/ Product Complaint handling
支持药品生产企业完成产品质量投诉调查。
Support domestic product manufacturer site to complete product quality complaint investigations.
接收和分类，对投诉进行分类并将其转发到现场进行快速调查；
Intake and triage where they classify the complaint and forward to site for investigation of its expedited.
向当地和全球管理层同事发出加急投诉通知；
Notification of Expedited Complaints to Local and Global Management colleagues.
投诉样本的接收和评估；
Receipt and assessment of the complaint sample.
将投诉转发给相关工厂或对投诉进行技术评估；
Forwarding of complaint to relevant plant or technical assessment of complaint.
准备产品投诉调查包；
Preparation of product complaint investigation package.
追踪、跟进调查；
Tracking and follow up of investigation.
对调查数据和报告进行技术评价；
Technical evaluation of investigation data and report.
跟进和审查纠正和/或预防措施；
Follow up and review of corrective and/or preventative actions.
向管理层升级投诉趋势；
Escalate complaint trends to Management.培训/ Training
创建SOP或其他OJT课程。
Create SOP or other on-job training courses.
建立培训课程并根据需要分配培训
Establish Training Curriculum and assign training as required.
制定年度培训计划并跟踪培训进度
Prepare annual training plan and track the training proceed.
完成被分配的培训
Complete assigned trainingPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Quality Assurance and Control#LI-PFE
