Total 2 Quality Assurance / Control job vacancies in CHN - GD - Guangzhou

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.

The Manager, Medical Quality Governance (MQG) China, manages efforts and activities needed to enable and sustain Quality and Inspection Readiness across category team within scope of Pfizer’s Medical Quality Management System, for the China Region (including Hong Kong & Macau).

MAIN REPONSIBILITIES / DUTIES

Quality Management Under the oversight of the MQG Lead, China,

• Drive the Medical Quality program and strategies and overall culture of Quality within China Region
• Lead MQG risk assessment activities and provide strategic input for the MQG Strategic and Quality Plans.
• Ensure the development and maintenance of the Country Quality Plans.
• Design and implement MQG risk mitigation strategies in collaboration with relevant stakeholders.
• Monitor and drive quality performance for the China Region.
• Provide quality consultancy to the colleagues in the China Region, demonstrating knowledge and understanding of the individual markets.

Audits and Inspections

• In collaboration with the China MQG Lead and Country Medical Directors/ leads, manage PCO Medical Inspection Readiness, including Communication, Documentation,
• Training, Quality and Inspection Readiness Plan, Process and Risk Controls.
• Monitor the country audit/inspection outcomes, share learnings, flag areas of concern to China MQG Lead/Country Medical Directors/leads.
• Understand Audit/Inspection trends and ensure timely action.
• Enable compliance to QMS07 and QMS13 requirements by promoting the use of the professional record repositories and contributing to PCO medical training curricula maintenance.
• Provide support for regional/country audits and inspections, as needed.

CAPA Management and Execution

• Act as the local technical expert on QMS01 and provide guidance to local colleagues when necessary.
• Ensure effective management of quality events (QEs) and Corrective and Preventive Actions (CAPAs) for China, as per Pfizer requirements.
• Continuously monitor QE and CAPA performance within China.
• Upon identification of risk or potential quality events, escalate as per Pfizer standards.
• Act as Quality Representative for the QEs within China.
• Conduct root cause analysis in consultation with local stakeholders and as per Pfizer requirements to identify effective CAPAs.
• Ensure effective implementation of CAPAs by local stakeholders.

SOPs and Other Procedures

• Partner with the China MQG Lead to drive implementation of policies and procedures in scope of MQG in China.
• Secure that proper control and oversight are in place to ensure compliance of country Medical controlled documents.
• Training.
• Support the China MQG Lead to ensure consistent training and communication plans for China.
• Facilitate country training compliance.

Other

• Lead and/or support global/regional quality related projects.
• Promote culture of quality across medical team and Platform Lines, where appropriate.
• Interact with internal and external networks.
• Demonstrate value proposition of MQG to internal and external stakeholders.
• Ensure appropriate information and communication management within China under the oversight of China MQG Lead.

REQUIRED SKILLS

Education & Experience

• Scientific or technical degree is mandatory e.g. Bachelor of Science/Pharmacy; Medical Degree, Masters Degree would be preferred.
• Preferably over 2-5 years’ experience.

• Experience in medical affairs preferred; experience in regulatory/ pharmacovigilance/ medical information/ clinical research acceptable; experience managing stakeholders from commercial/ marketing will be valued
• Supervisory experience in a matrixed organization is valued.
• Experience in managing multiple complex projects is valued.

Technical/Functional Competencies:

• Excellent command of Cantonese and English.
• Experience in navigating a large, complex matrix organization and managing stakeholders’ interests.
• Strong project management skills.
• Experience in developing and executing training at all levels of the organization.
• Excellent analytical skills with a demonstrated ability in risk identification, measurement and assessment, risk monitoring, reporting and escalation.
• Ability to work in a fast-paced and demanding environment.
• Strong organization and planning skills.
• Ability to communicate well within all levels of Pfizer with high level of influence and impact skills.
• Senior management engagement and communication skills.
• Ability to travel as required.

#LI-PFE

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