Supply Chain Quality Supervisor-Suzhou/Shanghai

解决产品质量合规问题.Resolution of Product Quality Compliance Issues

偏差处理/Deviation Management:

• 确保所有相关生产基地在整个生产过程中的任何调查、OOS、变更控制、投诉和任何其他与质量相关的事项都已关闭

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.

• 参与地区质量审查小组 （AQRT） 会议期间确定的行动在本地的实施情况，例如召回、与监管机构的沟通、当地纠正/预防措施
• 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.

• 参与进口产品的上市后变更，如果有与质量相关的行动项目（如CoA/CoC修改等），与ESOQ和工厂进行沟通。

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 training

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Quality Assurance and Control

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