Total 4 Transportation / Logistics job vacancies in Shanghai,CHN

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.

At Fiskars Group we are unified and driven by our common purpose: pioneering design to make the everyday extraordinary. Join our team and seize the extraordinary opportunity to influence the everyday!

• Ensure NPD tasks related to engineering are performed: translating and managing documentation, samples, testing, drawings, tools etc.  
• Ensuring that vendors understand and comply with specifications and control plans. Securing product launches and efficient production by on-site support.  
• On site support;  zero runs, control points, line efficiency, in-line inspections
• Suggest improvement to new and existing products to improve quality, save cost or increase efficiency.
• Securing total cost competitiveness by competition, cost breakdowns and efficient negotiation process with suppliers
• Screening potential Vendors and technologies, sharing the knowledge with Sourcing Category Managers and NPD
• Implementing sourcing category strategy in Vendor Base
• Monitoring Vendor's performance ref. Targets and goals. Ensuring corrective action planning and implementation
• Monitoring vendor capacity to guarantee on-time delivery and improve lead time
• Monitoring industry development in the region (technologies, increases of the cost factors etc). Controlling IPR and CoC violations
• Product and packaging improvements, customer feedback, claims, regular and frequent follow up meetings with BA
• Train suppliers and organization on new requirements, Fiskars Quality standards, customer experienced quality.
• Supporting virtual sourcing category team and contributing in material area specific matrix team in Sourcing office.  Coaching Sourcing Specialists in completing high quality NPD projects.
• Contributing Vendor Relationship Management. Contracting, audits, Vendor evaluation process. Vendor Development Programs. Participate monthly reviews. Regular Business Reviews (together with SM and  BU category managers.)
• Securing Vendor's capacity in long horizon (1-3 years) and supporting Procurement in short term supply constrains

Last day of application:

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At Fiskars, we value providing benefits that matter to you and cater to our diverse global workforce, no matter where you are in the world. While benefits may vary based on location, here are some of the incredible offerings you can expect when joining our team:

Competitive Compensation: We ensure that our employees are fairly compensated based on industry standards and local market factors.

Health and Wellness: Your well-being matters to us, no matter where you are. We offer various health and well-being focused programs and coverage, adapted to the requirements of each region.

Work-Life Balance: We understand the need for balance in your life. Our paid time off plans and flexible work arrangements and policies are designed to accommodate local customs and personal commitments, enabling you to thrive in both your professional and personal life.

Professional Development: We believe in nurturing talent and supporting professional growth. Through training programs, skill development initiatives and learning resources, we empower our employees to reach their full potential.

Inclusive and Diverse Environment: We value diversity and promote inclusivity. Join a workplace where your unique background and perspectives are celebrated, fostering collaboration and respect across all our markets.

Recognition and Rewards: We believe in celebrating and recognizing the contributions of our employees worldwide. Our recognition programs are designed to acknowledge exceptional performance and achievements, ensuring that your efforts are celebrated and valued.

Vested Interest: Through our Employee Share Purchase Plan (ESPP), you have the opportunity to invest in Fiskars Group and become a proud co-owner, sharing in the success and growth of the company.

Employee Discounts: We want to ensure our team members make each day the extraordinary with use of our products and offer product discounts across our brands.

Please note that specific benefits may vary based on local regulations, market conditions, and other factors. We are committed to providing competitive and meaningful benefits to our employees in every market we operate.

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Partner:  Contribute & improve satisfactions of internal partners, and performance of logistics service providers:

• Work daily with MED Sales Coordinators, and fulfill order processing (primarily PO processing), import logistics, SAP transactions (e.g. GR, GI, Goods Transfer, Billing, etc.), insurance claiming (if needed), return (if needed), etc.
• Define service requirements for 3PL’s, check payments to 3PL’s, etc.
• Support other internal supporting functions, like F&A, IT, RA, Controlling, etc.

Productivity:

• Continuously improve quality, shorten/stabilize lead-time, & reduce cost
• Deliver process-improvement quick-win’s, and contribute BIIB's (business idea in brief, i.e. validated quick-win opportunity)

People:

• Attend generic trainings, share learnings, continuously develop selves, and act as knowledge owners

Product:

• On-time in-full & high-quality delivery
• Ensure inventory accuracy of MED machines, accessories, and demos
• Maintain related material codes in SAP
• Other tasks assigned

Process:

• Compliance & excellence
• Compliance with external regulations and internal policies
• Contribution to process excellence

Education / 教育背景

• Minimum bachelor degree in Logistics Management, International Trade, Supply Chain Management, or equivalent

Experience /经验

• 5-8 years working experiences in fields of international order processing and/or logistics
• management
• Experienced SAP user
• Experienced in international air freight operations
• Experienced in logistics knowledge  of BLP & FTZ

Other skills /其他技能

• Fluent English & Chinese both written and spoken
• Good command of MS office
• Result-oriented & able to work under pressure
• Good communication and interpersonal skills with team spirits

Your ZEISS Recruiting Team:

POSITION SUMMARY:

This position is responsible for managing the business relationship, operations and performance of  Dalian CMO that launch, manufacture and supply finished pharmaceuticals for Pfizer in China in different dosage forms. Through a matrix organization, this position will provide operations leadership to a Virtual Site Operations Team (VSOT) which includes representatives from PGS Supply Chain, Quality, Technical Services, Procurement, EHS and Finance and which – together - has responsibility for launch preparations and for routine quality, supply and cost of finished pharmaceutical products from DL CMO. She or he works closely with our Customers in Commercial Business Units, in Alliance and BD to bring to market and to manage supply of our products for Patients. The External Supply Operations Lead develops and manages implementation of strategy and tactical execution to secure timely launch and product supply and to achieve cost improvement targets and other outcome metrics. She or he also contributes strongly to the development and execution of PGS Emerging Markets &China and External Supply strategies. 

POSITION RESPONSIBILITIES:

• The ES Operations Lead is responsible for the business relationship and for the performance of Dalian CMO across a range of technologies that may include solid oral dose and sterile injectables etc. Leadership on short-term tactics as well as on long-term strategies ensures that CMO contributes to achieving the ES targets and strategic objectives.
• She or he provides leadership through a matrix organization to all members of the VSOT including but not limited to quality, supply chain planners, procurement, EHS, finance and technical project colleagues. The ES Operations Lead is accountable for the results of the VSOT. The activities and responsibilities of the VSOT include:
  • Own P&L responsibility for selected portfolio including direct accountability for contract negotiations and external relationship management with the contractor base up to CEO level
  • Collaborate with local China team, global team and VSOT members to set up and maintain the relative systems to meet China MAH requirement.
  • Development and execution of manufacturing and supply plans and meet market demand for product and meet or exceed supply performance targets
  • Collaborate with stakeholders globally including but not limited to Product Portfolio Leaders, Brand Supply leaders, Commercial, Business Development and PGS leadership
  • Act as a “Change Control Committee” for relevant changes.
  • Develop and execute tactical plans for continuous improvement of CMO performance in the areas of product quality, environmental health and safety, compliance, customer service and product cost.
  • Review of the status of deviations which impact or may affect product supply.  The ES Operations Lead is responsible to secure correct and timely closing of relevant deviations, and when necessary, lead closure of investigations that have not been properly addressed by the CMO.
  • With the request from line manager, to co-ordination of required activities across PGS to bring-to-market supply new Products which require sourcing from a 3rd Party, and which were acquired through business development and Alliance deals
  • Lead /support 2nd wave MAT & PLENC project
  • Support Dalian site separation project as necessary

• Oversee and secure timely execution of new product introduction, launch, process changes (including changes of materials and API), product enhancement, and product transfer programs.  
• Ensure that product supply, quality, compliance and cost issues are adequately addressed by making extensive use of Operational Excellence tools and mobilizing the necessary resources for support in all required areas.  Lead these cross-functional teams where required.
• Collaborate with EH&S to ensure CMO compliance with environmental, health and safety regulations and alignment with Pfizer’s Climate and Sustainability strategy.
• Secure effective communication of key product supply issues to stakeholders – this includes accurate and timely updating the weekly supply and hot topic reports in alignment with the IMEX approach.
• Partner with ES Quality to ensure CMO comply with regulatory requirements, cGMP’s, Pfizer Quality Standards and Standard Operating Procedures.
• Manage the cost reduction program:
  • Identify cost reduction opportunities with CMO and supply partners
  • Validate the financial impact and ensure the opportunities are captured and reported in the Long-Range Plan and the Operational Plan
  • Oversee execution and implementation, lead the team for execution as appropriate
  • Meet or exceed annual budget cost reduction target
• Maintain awareness and intelligence of potential new sourcing and business development opportunities and identify strategic sourcing partners who share common vision/values for the manufacture/packaging/testing of pharmaceutical products
• Secure compliance with Legal Requirements of the “Foreign Corruption Policy Act” (FCPA”) and related other legislation as directed by the relevant Pfizer Corporate Policies.  The ES Operations Lead is accountable for appropriate documentation of compliance with all such requirements.
• Lead assigned project and initiatives for his/her portfolio of contractors including but not limited to:
  • Serialization
  • Business Continuity Plans and management of risk
  • Supplier Network Collaboration
  • Environmental Sustainability
• Must be based in Dalian. ~15 travel required

KEY PERFORMANCE INDICATORS:

Launch and Supply performance: sustained ability to meet launch targets and other key ES Operations Outcome Metrics Compliance: Achievement of Quality and EH&S metrics Demonstrated continuous improvement of performance Product cost reduction. MAT & PLENC project on time

TECHNICAL SKILL REQUIREMENTS:

Level of Education:  Minimum Bachelor degree of medical or Pharmacy education background; MBA preferred
 

Experience – At minimum, greater than 15 years of experience in one or more Pharmaceutical supply functions; e.g. in Operations, Technical Services, Supply Chain, Quality Operations, External Supply and/or Procurement.

Proven experience in manufacture and supply of pharmaceuticals in different forms – solid oral dose, sterile injectables,  vaccines.

Project Management experience is also highly desirable.

Languages: Fluency in Mandarin and in English.  

Other Specifics & know-how: Excellent verbal and written communication skills including a demonstrated ability to lead and participate in teams at all levels of management is required.  Well developed interpersonal skills (leadership, integrity, team orientation, flexibility, creativity; experience in projects that require collaborative approaches; strong analytical skills; ability to understand business issues and processes; knowledge and understanding of pharmaceutical manufacturing processes and regulatory requirements. 

ORGANIZATIONAL RELATIONSHIPS:

Add an organization chart, clearly indicating where the function is positioned within your group, or, alternatively, use the chart below.  List the title of the jobholder’s supervisor, the next level supervisor, the peers (other positions reporting to the supervisor) and subordinates. Show total number of employees reporting to the subordinates and indicate the functions of each subordinate.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.