Nantong Drug Product Senior Specialist, Nantong QA JS 226000

Job description

About the role: As a Drug Product Senior Specialist in Nantong QA, you’ll oversee on-site quality for drug product manufacturing. You’ll help ensure production activities meet GMP requirements and company quality standards, supporting compliant operations and product release. Working with Production, QC and Engineering, you’ll oversee manufacturing activities, review batch records and quality documents, and support investigations, audits and inspections. Your work will help teams identify quality risks and address them in a timely manner. Your contribution: Oversee drug product manufacturing activities, including solution preparation, filtration, filling, packaging, cleaning and disinfection, and line clearance, to ensure compliance with GMP and company quality standards Review batch production records and related documents for completeness, accuracy and compliance Participate in investigations and resolution of deviations, change controls and corrective and preventive actions Review and improve production procedures, batch records and other quality documents Support product release by ensuring required documentation reviews are complete Participate in internal and customer audits and regulatory inspections, and help implement corrective actions A good match: Bachelor’s degree or higher in bioengineering, biotechnology, pharmacy, chemistry or a related field Experience in pharmaceutical manufacturing quality management, ideally with on-site QA experience in drug product production Knowledge of China GMP regulations, pharmaceutical quality management systems and drug product manufacturing processes Familiarity with deviation investigations, change controls, corrective and preventive actions, and batch record review Experience in on-site QA for aseptic processing, fill-finish or biologics manufacturing is an advantage Strong communication and problem-analysis skills, a responsible and detail-oriented approach, and CET-4 English proficiency or above, with the ability to read English quality and technical documents 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 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 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