Nantong QA制剂专员 JS 226000

Job description

About the Role: As a QA Specialist in Drug Product Manufacturing, you will play a pivotal role in ensuring the quality and compliance of our drug product manufacturing processes. You will contribute to maintaining high standards of operational excellence by overseeing production activities, managing deviations, and ensuring adherence to GMP regulations. This position offers an opportunity to work in a dynamic environment where your expertise will directly support BioNTech’s mission of pioneering immunotherapies for serious diseases. Your Contribution: Supervise key drug product manufacturing processes, including weighing, solution preparation, vial washing, filling, capping, labeling, packaging, cleaning/disinfection, line clearance, and storage Review and approve SOPs related to drug product manufacturing operations Support the optimization of quality management documents for drug product production Audit production data and batch records to ensure accuracy and compliance Review deviations, change controls, CAPAs; participate in OOS investigations Oversee the release of drug products and handle non-conforming materials during production Manage clinical drug returns and ensure proper handling procedures are followed Address product complaints, returns, and recalls effectively Monitor environmental conditions in manufacturing areas and confirm alarms as needed Assist with material release processes and supplier qualification related to drug product manufacturing Collaborate on technical transfers for drug product manufacturing processes A Good Match: 3–5 years of experience in pharmaceutical quality management or related fields; prior QA experience in drug product manufacturing is preferred Familiarity with aseptic processing and biological drug production is an advantage Strong knowledge of Chinese GMP regulations and pharmaceutical quality management systems In-depth understanding of drug product manufacturing workflows and on-site quality requirements Skilled in managing deviations, change controls, CAPAs, batch record reviews, and other quality-related activities Excellent communication and problem-solving skills with a detail-oriented mindset; capable of working effectively in a production environment Proficiency in English (CET-4 or above), with the ability to read technical documents and quality files Join us at BioNTech as we strive to transform lives through innovative therapies. If you are passionate about quality assurance in pharmaceutical manufacturing and thrive in a fast-paced environment dedicated to excellence—this role is for you! 立即申请 » 查找类似职位: Alle Stellen, All Jobs Terms of Use General Terms and Conditions Data Privacy Statement Imprint Cookie Settings © 2024 BioNTech SE. All rights reserved × Cookie 许可管理器 当您访问任何网站时，它可能存储或检索浏览器中的信息，大多数为 cookie 形式。我们尊重您的隐私权，因此您可以选择不允许某些类型的 cookie。但是，阻止某些类型的 cookie 可能影响您的网站体验以及我们能够提供的服务。 需要的 Cookie 需要这些 cookie 才能使用此网站，无法将其关闭。 需要的 Cookie 显示更多详细信息 需要的 Cookie 提供者 描述 已启用 SAP as service provider 我们使用以下会话 cookie，使网站正常工作需要所有这些 cookie： "route" 用于会话粘性 "careerSiteCompanyId" 用于将请求发送至正确的数据中心 "JSESSIONID" 在会话期间位于访问者的设备上，以便服务器能够识别访问者 "Load balancer cookie"（实际的 cookie 名称可能不同）阻止访问者从一个实例跳转到另一个实例 需要来自提供者 SAPasserviceprovider 的 cookie，无法将其关闭 功能 Cookie 这些 cookie 可以通过记住您的登录详细信息、优化视频性能或提供有关如何使用网站的信息来在此网站上提供更好的客户体验。您可以随时自由选择接受或拒绝这些 cookie。请注意，如果您不接受这些 cookie，这些第三方提供的某些功能可能受影响。 同意所有 功能 Cookie 显示更多详细信息 功能 Cookie 提供者 描述 已启用 YouTube YouTube 是一项视频共享服务，用户在此可以创建自己的档案，上传视频，以及观看、点赞和评论视频。选择拒绝 YouTube cookie 将无法观看 YouTube 视频或与其交互。 Cookie 政策 隐私政策 条款和条件 同意来自提供者 YouTube 的 cookie 确认我的选择 拒绝所有 Cookie 接受所有 Cookie