Supply Chain Quality Supervisor-Suzhou/Shanghai

3 weeks ago

Suzhou, China Pfizer Full time

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

Pfizer 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

  • Supply Chain Manager, Furniture

    3 weeks ago

    Suzhou, China NPA WorldWide Full time

    Job description: This dynamic and experienced Sourcing Manager drives the expansion into new markets through the development of a profitable B2B network. He or she will be responsible for overseeing the sourcing and supply of furniture products that can be sold through B2B channels worldwide. This role is pivotal in establishing successful product lines as...

  • Reporting and Planning Controller, Supply Chain

    3 weeks ago

    Suzhou, China KONE Full time

    Overview of role purpose & scope： Provide timely and accurate financial information for management decision-making and financial reporting for Continent Supply Chain Key responsibilities for this role : Reporting and planning for continent Supply Chain •Management reporting and planning in monthly and quarterly cycles•Budgeting•Key contact...

  • Quality Control Manager, Suzhou China

    3 weeks ago

    Suzhou, China Keller Executive Search Full time

    Our client, a bridal apparel brand based in Suzhou, China, is seeking a Quality Control Manager to oversee and ensure the highest level of quality in their production processes. As the QC Manager, you will play a crucial role in maintaining the company's reputation for delivering exceptional bridal dresses to their customers.Responsibilities: Develop and...

  • GBS - 采购热线服务专员Junior Specialist

    2 days ago

    Suzhou, China Siemens Ltd., China Full time

    Siemens Global Business Services（GBS） is engaged in providing innovative,designed, improved and efficient services in Accounting & Finance, HumanResource and Supply Chain Management areas. In shared service market, we haverich and professional technical background. We can provide high qualitytailor-made value added services to our customers. Our...

  • Supply Chain Planning Analyst

    16 hours ago

    Suzhou, Jiangsu, China Caterpillar, Inc. Full time

    Career Area:Supply Chain and LogisticsJob Description:Exciting Opportunity at Caterpillar Inc.Join the global team at Caterpillar where we value not only the work we do, but also each other. We are the innovators, problem solvers, and creators of a better world. Progress and innovation are not just words here - we bring them to life with our customers, in...

  • People Lead, Suzhou East Plant

    3 weeks ago

    Suzhou, China Mondelēz International Full time

    Description Are You Ready to Make It Happen at Mondelēz International? Join our Mission to Lead the Future of Snacking. Make It Possible. Our employees are key ingredients to our success,​ and you will be responsible for HR support to a specific plant(s) on topics such as talent management, leadership development, early career programs,...

  • Live-in Mathematics

    2 weeks ago

    Suzhou, China AuPair Full time

    Hi, we are a family who live in Suzhou, China. Which is a beautiful garden city close to Shanghai, 20 minutes by train, but with a reasonable living cost. There is a saying that “Paradise above, Suzhou and Hangzhou below.” We live in a beautiful city. My husband travels a lot and I take care of my son most of the time. He goes to kindergarten during the...

  • GBS -Digitalization Expert - Redwood & Quality

    3 weeks ago

    Suzhou, Jiangsu, China Siemens Full time

    Job Family: FinanceReq ID: 417809Siemens Global Business Services(GBS) is engaged in providing innovative, designed, improved and efficient services in Accounting & Finance, Human Resource and Supply Chain Management areas. In shared service market, we have rich and professional technical background. We can provide high quality tailor-made value added...

  • Head of Plant Quality.

    4 weeks ago

    Suzhou, China ZF Group Full time

    Req ID Zhangjiagang, China We are looking for a Head of Plant Quality in our location Zhang Jiagang Distinct, Suzhou. Your Task Develop, implement and manage quality KPI under control including customer/process/supply PPM, customer complaints, conduct yearly/quarterly/monthly/weekly review, develop corrective and preventative action, work with...

  • GBS - 供应链专员 - 物料合规

    3 weeks ago

    Suzhou, China Siemens Ltd., China Full time

    （GBS） is engaged in providing innovative, designed, improved and efficient services in Accounting & Finance, Human Resource and Supply Chain Management areas. In shared service market, we have rich and professional technical background. We can provide high quality tailor-made value added services to our customers. Our services also cover E2E digital...

  • GBS -Digitalization Expert - Redwood & Quality

    3 weeks ago

    Suzhou, China Siemens Ltd., China Full time

    （GBS） is engaged in providing innovative, designed,improved and efficient services in Accounting & Finance, Human Resource andSupply Chain Management areas. In shared service market, we have rich andprofessional technical background. We can provide high quality tailor-madevalue added services to our customers. Our services also cover E2E...

  • Safran Asia Supply Chain- Asia Supplier Performance Engineer

    1 week ago

    Suzhou, China Safran Full time

    Job Description 1. Drive, support and secure operational KPI performance for the different functions covered by Asia Supply Chain team – KPI dashboard defined in collaboration with Asia SCM director. 2. Support execution of Service agreement signed by Asia Supply Chain Department 3. Support KPI improvement action plan in collaboration with each job...

  • Quality Manager

    1 month ago

    Suzhou, China Marel Full time

    About the Job A true choice. You can experience it, too. At Marel , we are looking for Quality Manager , based in Kunshan City, China . This role is responsible for continuous improvement of Marel product and processes and sys-tems throughout the entire supply chain. Assures early quality engineering involvement in the Launch process of New...

  • Product & Process Quality Engineer

    2 weeks ago

    Suzhou, China CAREL Full time

    Company Description CAREL is an innovative global high-tech company, leader in the evolution of control technology and humidification for air conditioning and refrigeration, listed at the Italian stock exchange. To foster our continuous growth, we're strengthening our organization looking at smart professionals willing to join the team as...

  • Quality Supervisor

    4 weeks ago

    Suzhou, China Phillips-Medisize Full time

    Your Job Responsible for normal operation of the Quality laboratory, instrument calibration process, inspection of the NPI phase and production phase, including the arrangement of incoming, in-process and outgoing inspection on time. What You Will Do 1.Responsible for the management of QC leader, Quality technician and inspector, including resource...

  • Quality Engineer

    4 weeks ago

    Suzhou Shi, China Mondelēz International Full time

    Description Are You Ready to Make It Happen at Mondelēz International? Join our Mission to Lead the Future of Snacking. Make It With Pride. ...

  • sr mfg

    1 week ago

    Suzhou, Jiangsu, China TE Connectivity Full time

    SR MFG & PROCESS DVL ENGINEERAt TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.Job OverviewTE Connectivity's Manufacturing and Process Development Engineering Teams significantly impact LEANPD driven new product development projects, driving for...

  • sr mfg

    1 week ago

    Suzhou, Jiangsu, China TE Connectivity Full time

    SR MFG & PROCESS DVL ENGINEERAt TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.Job OverviewTE Connectivity's Manufacturing and Process Development Engineering Teams significantly impact LEANPD driven new product development projects, driving for...

  • MEMS产品工程师_BST

    3 weeks ago

    Suzhou, China Bosch Full time

    Job Description As part of the global operation team, the product engineer in the Bosch Sensortec Suzhou team is responsible for the new products’ ramp up and monitoring the series product’s QCD* aspects via efficient SE-team work. *QCD: Quality, Cost, Delivery •  Lead cross functional SE-team • Monitor process deviations (especially yield)...

  • Intercompany Back Office Specialist

    3 weeks ago

    Suzhou, China Prysmian Group Full time

    You will join China Back Office team and base in Suzhou, your main responsibilities are: To execute all enquiries from affiliates, analyses capability with related dept. and prepare compliant offer in order to secure the order; Execute order received from affiliates, understood well the requirement, and follow up till POD; Execute and maintain order from...