Our Team我們的團隊：
Manufacturing & Supply consists of 3 manufacturing platforms based on global business units, as well as supporting functions of Quality, Market Supply and Strategy. We are committed to making best class medicines with excellent strategies and tools and delivering them to our patients.
制造與供應(yīng)事業(yè)部包含以3個全球事業(yè)部為基礎(chǔ)的制造平臺，以及質(zhì)量、供應(yīng)商、精益戰(zhàn)略等支持部門。致力于用優(yōu)異的戰(zhàn)略和工具制造優(yōu)質(zhì)的藥品并傳遞到患者手中。
Main responsibilities職責(zé)描述：
Please indicate here the main job responsibilities請列舉該職位的主要工作職責(zé)。
General Mission職責(zé)概述
? Implement and monitor quality system for quality third party management, document/record management, Training management, Printed material design and approval process management and quality maturity index project. Ensure quality system running effectively, compliance to CGMP and Sanofi global requirement.
? 執(zhí)行和監(jiān)督質(zhì)量體系的運行，負(fù)責(zé)質(zhì)量文件、記錄管理、培訓(xùn)管理質(zhì)量成熟度項目及Fly/馬賽克項目，確保質(zhì)量體系被有效運行，符合現(xiàn)行GMP和賽諾菲總部要求。
Activities具體職責(zé)
Documentation System 文件體系管理
? Overseeing and managing the creation, revision, and obsolescence of all GxP documents.
? 監(jiān)督并管理所有 GxP 文檔的創(chuàng)建、修訂和作廢。
? Collaborating with other departments to ensure documentation needs are met and processes are aligned.
? 與其他部門合作，確保滿足文檔需求并且管理流程達成一致。
? Ensuring the documentation package is kept lean (i.e., avoiding redundancies and duplication)
? 確保文檔包保持精簡（即避免冗余和重復(fù)）
? Ensuring with the support of relevant experts that all documentation complies with regulatory and company requirements.
? 在相關(guān)專家的支持下，確保所有文檔都符合法規(guī)和公司要求。
? Reviewing and approving quality system documents to ensure harmonization, accuracy, completeness and compliance with writing rules and company strategies.
? 審查和批準(zhǔn)質(zhì)量體系文件，以確保協(xié)調(diào)性、準(zhǔn)確性、完整性并符合撰寫原則和公司策略。
? Ensuring document distribution and access complies with the information classification level.
? 確保文檔分發(fā)和訪問符合信息分類級別。
? Collecting needs for documentation changes, prioritizing and managing documents update.
? 收集文檔更改的需求，確定文檔更新的優(yōu)先級并管理
? Ensure the implementation of an efficient documentation process, in conformance with Global documentation strategies supporting simplification, harmonization and digitalization. Ensure local implementation of the necessary changes.
? 確保實施高效的文檔流程，符合支持簡化、協(xié)調(diào)和數(shù)字化的全球文檔戰(zhàn)略。確保在本地實施必要的變更。
? Preparing documentation for internal, external audits and inspection, ensuring all required documents are up-to-date and accessible.
? 為內(nèi)部、外部審計和檢查準(zhǔn)備文件，確保所有必需的文件都是最新的和可訪問的。
? Managing the documentation team and ensuring their proper qualification for their activities.
? 管理文檔團隊并確保他們具備合適的資質(zhì)，能夠勝任其活動。
? Being representative of the site in the CoP documentation led by the global and if requested participating in the CoE and ensure local communication.
? 代表杭州工廠參與Global領(lǐng)導(dǎo)的文檔管理 CoP 會議，并應(yīng)要求參與 CoE 并確保本地溝通。
Training Management 培訓(xùn)管理
? Developing and implementing annual training programs to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory standards.
? 制定和實施年度培訓(xùn)計劃，以確保符合良好生產(chǎn)規(guī)范 （GMP） 和其他監(jiān)管標(biāo)準(zhǔn)。
? Collaborating with department heads to identify training needs and developing customized training plans.
? 與部門負(fù)責(zé)人合作，確定培訓(xùn)需求并制定定制的培訓(xùn)計劃。
? Supporting the managers in the establishment of the curricula for the different areas.
? 支持管理人員為不同領(lǐng)域建立課程包.
? Conducting training sessions for new hires and existing employees on specific topics.
? 為新員工和現(xiàn)有員工舉辦特定主題的培訓(xùn)課程。
? Monitor the completion of the training plan to identify risks and weaknesses.
? 監(jiān)控培訓(xùn)計劃的完成情況，以識別風(fēng)險和薄弱點。
? Evaluating training effectiveness through assessments, feedback, and performance metrics.
? 通過評估、反饋和績效指標(biāo)評估培訓(xùn)效果
? Updating training materials with the support of the relevant subject matter expert to reflect changes in regulations, procedures, and best practices.
? 在相關(guān)主題專家的支持下更新培訓(xùn)材料，以反映法規(guī)、程序和最佳實踐的變化。
? Leading continuous improvement initiatives to enhance training material and processes.
? 領(lǐng)導(dǎo)持續(xù)改進計劃，以改進培訓(xùn)材料和流程。
? Providing support during regulatory inspections and audits by presenting training records and training process and material.
? 通過提供培訓(xùn)記錄、培訓(xùn)流程和材料，在監(jiān)管檢查和審計期間提供支持。
? Managing the training team and ensuring their proper qualification for their activities.
? 管理培訓(xùn)團隊并確保他們具備合適的資質(zhì)，能夠勝任其活動。
? Being representative of the site in the CoP training led by the global and if requested participating in the CoE and ensure local communication.
? 代表杭州工廠參與Global領(lǐng)導(dǎo)的培訓(xùn)管理 CoP 會議，并應(yīng)要求參與 CoE 并確保本地溝通。
Quality Maturity Index 質(zhì)量成熟度項目
? Quality Maturity Index: Responsible for regular communication and updates of the Quality Maturity Index (QMI).
質(zhì)量成熟度：負(fù)責(zé)質(zhì)量成熟度指數(shù)（QMI）的定期溝通和更新；
Global Document Gap 分析
Fly/馬賽克項目執(zhí)行
其他
? Conduct boss assigned other works.
領(lǐng)導(dǎo)安排的其它工作；
? Be responsible for HSE in his/her position and job.
對本崗位的職業(yè)健康安全環(huán)境工作負(fù)責(zé)。
About you 任職資格:
List here ideally the must-haves criteria to be successful on the role.
請列出勝任該職位所必須具備的條件。
Experience 經(jīng)驗
? 5 years of experience in quality management systems in the pharmaceutical industry. Including in the development, review, and approval of quality system documents. Ensuring compliance with GMP and other regulatory standards and experience in developing, implementing, and evaluating training programs, particularly those related to quality systems and regulatory compliance.
? 5 年制藥行業(yè)質(zhì)量管理體系經(jīng)驗。 包括質(zhì)量體系文件的制定、審查和批準(zhǔn)。確保遵守 GMP 和其他監(jiān)管標(biāo)準(zhǔn)，并在制定、實施和評估培訓(xùn)計劃方面擁有豐富的經(jīng)驗，尤其是與質(zhì)量體系和法規(guī)合規(guī)性相關(guān)的培訓(xùn)計劃
Skills 技能
? Ability to analyze complex data, identify trends, and make data-driven decisions to improve quality and compliance.
能夠分析復(fù)雜數(shù)據(jù)、識別趨勢并做出數(shù)據(jù)驅(qū)動的決策以提高質(zhì)量和合規(guī)性。
? Excellent problem-solving abilities to address and resolve quality issues, including root cause analysis and implementation of corrective actions.
出色的問題解決能力，能夠解決質(zhì)量問題，包括根本原因分析和糾正措施的實施。
? Strong project management skills to oversee multiple quality initiatives, manage timelines, resources and ensure successful completion of projects. Present project outcomes to senior management.
強大的項目管理技能，能夠監(jiān)督多項質(zhì)量計劃，管理時間表，資源并確保成功完成項目。向高級管理層展示項目成果。
? Ability to meticulously review and manage documents to ensure accuracy, completeness, and compliance with regulatory standards.
能夠仔細(xì)審查和管理文檔，以確保準(zhǔn)確性、完整性并符合監(jiān)管標(biāo)準(zhǔn)。
? Proficiency in using electronic document management systems and other relevant software tools for document control and management.
熟練使用電子文檔管理系統(tǒng)和其他相關(guān)軟件工具進行文檔控制和管理。
? Ability to create effective training programs and materials that meet the needs of the organization and comply with regulatory standards.
能夠創(chuàng)建滿足組織需求并符合監(jiān)管標(biāo)準(zhǔn)的有效培訓(xùn)計劃和材料。
? Proficiency in evaluating training effectiveness through data analysis, assessments, and feedback to continuously improve training programs.
熟練通過數(shù)據(jù)分析、評估和反饋來評估培訓(xùn)效果，以不斷改進培訓(xùn)計劃。
? Strong understanding of regulatory requirements and the ability to ensure training programs align with these standards.
對法規(guī)要求有深刻的理解，并能夠確保培訓(xùn)計劃符合這些標(biāo)準(zhǔn)。
? Expertise in planning, organizing, and managing training projects, including setting timelines, allocating resources, and monitoring progress.
規(guī)劃、組織和管理培訓(xùn)項目的專業(yè)知識，包括設(shè)定時間表、分配資源和監(jiān)控進度。