1. Lead the establishment and maintenance of quality system and ensure the compliance with applicable regulatory requirements to support manufacturing, testing and distribution processes. 领导质量体系的建立和维护,并确保其符合适用的法规要求,以支持生产、 检测和发运过程;
2. Oversee and assign resources to support the establishment and execution of the product compliant system, key elements of the quality system, document management system and training management system. 监督并为产品合规体系、质量体系关键要素、文件管理体系和培训管理体系 的创建与执行分配资源;
3. Assign resources and personnel to support and supervise the operation of Manufacturing, Engineering, IT&Digitalization, QC and MML, to assure the compliance with GMP requirements. 分配资源与人员来支持和监管生产、工程、信息及数字化部、QC 和物料管 理的运营,确保其符合 GMP 要求;
4. Review or approve quality system documents according to established procedure. 根据建立的程序执行质量体系文件的审核或批准;
5. Review or approve the supplier, including material supplier and service supplier according to established procedure. 根据建立的程序审核或批准供应商,包括物料供应商与服务供应商
6. Review or approve the quality events,such as surveys from deviation, OOS, complaint, return and recall, as well as corresponding CAPA activities according to established procedure. 根据建立的程序审核或批准质量活动,如偏差、OOS、投诉、退货、召回的 调查,以及相应的 CAPA 活动;
7. Review or approve change control, qualification and validation activities according to established procedure. 根据建立的程序审核或批准变更、确认和验证活动;
8. Assign resources and personnel to support the operation of CMC projects, to assure the compliance with GMP requirements and the achievement of project schedules. 分配资源与人员来支持 CMC 项目的运营,以确保符合 GMP 要求和实现项目进 度要求;
9. Assign resources and personnel to facilitate the internal, regulatory, client and third party audits. 为内部审计、监管机构检查、客户审计和第三方审计分配资源与人员;
10. Full time supervisor for the validation activities of CBL facilities, utility, system and APS to comply with cGMP requirement. 全职主管 CBL 的厂房,公用设施,系统和 APS 的验证活动,符合 cGMP 要 求;
11. Coordinating completion of qualification and validation for the facilities, utilities, system, and APS. Establishing and maintaining the validated state of direct-impact systems in compliance with Good Manufacturing Practice (GMP) in collaboration with system owners and project teams.协调完成设施、公用设施、系统和 APS 的确认和验证。与系统所有者和项 目团队合作,建立和维护符合良好生产规范(GMP)的直接影响系统的验证 状态;
12. Periodically updating the Validation Schedule related to facilities, utilities, system, and APS. 周期性的更新厂房,公用设施,系统和 APS 相关的验证时间表;
13. Implementing and maturing the CBL quality management systems related to qualification and validation lifecycle. Managing the validation group. 实施和完善与确认和验证生命周期相关的 CBL 质量管理体系。管理验证 组;
14. Preparing and/or approving Validation Plans for facilities, utilities, system and APS in collaboration with Subject Matter Experts. 与主题专家合作,准备和/或批准厂房、公用设施、系统和 APS 的验证计 划;
15. Preparing and/or approving protocols: DQ, IQ, OQ, and PQ. Preparing and/or approving validation summary reports. 准备和/或批准方案:DQ、IQ、OQ 和 PQ。准备和/或批准验证总结报告;
16. Generating, reviewing, and/ or approving of Qualification Deviations and managing their closure by the agreed dates. 生成、审查和/或批准资格偏差,并在商定日期前管理其关闭;
17. Reviewing Factory Acceptance and Site Acceptance Test (FAT and SAT) documents prepared by Vendors. Coordinating Protocol execution of testing with vendors and CBL personnel. 审查供应商准备的工厂验收和现场验收试验(FAT 和 SAT)文件。与供应商 和鼎康人员协调测试协议的执行;
18. Presenting the validation status of facility, utility, system and APS to Regulatory Inspectors and customers. 向监管检查员和客户展示厂房,公用设施,系统和 APS 相关确认和验证的 验证状态;
19. Completing and maintaining the approved quality management documentation covering the validation lifecycle of CBL facilities, utilities, equipment, and processes (i.e. VMP, VP, URS, FS, OS, Protocols, Reports). 完成并维护批准的质量管理文件,包括 CBL 设施、公用设施、设备和过程 的验证生命周期(即 VMP、VP、URS、FS、OS、协议、报告);
20. Identifying validation requirements for proposed changes and corrective actions. 确定拟定变更和纠正措施的验证要求;
21. Complying with, and continuously improving, the Company QMS. 遵守并持续改进公司质量管理体系;
22. Recruiting and management of Validation Staff. 验证人员的招聘和管理;
23. Planning and managing expenditure in line with budget for validation activities including purchase of capital equipment and consumables for test execution where required. 根据验证活动的预算计划和管理支出,包括必要时为测试执行采购资本设备 和耗材;
24. Selecting and purchasing equipment and consumables required to execute validation activities. 选择和采购执行验证活动所需的设备和耗材;
25. Setting validation budget and managing performance to approved budget. 设定验证预算,并根据批准的预算管理绩效;
26. Encouraging a culture of safe working practices through personal leadership and compliance with approved procedures for safety management within the Validation Group. 在验证小组内,通过个人领导和遵守批准的安全管理程序,鼓励安全工作实 践文化;
27. Compliance with corporate and site safety procedures. Zero lost time injuries for staff. 遵守公司和现场的安全程序、员工零工伤;
28. Lead the daily activities of the QA Department. 领导质量保证部门的日常工作;
29. Comply with the company's information security management related system and requirements. 遵守公司关于信息安全管理的相关制度和要求。
skills and experience required.
Education and professional background 学历及专业背景 BS degree and above or equivalent, scientific discipline preferred. 本科以上或同等学历,理工科优先。
Work experience 工作经验
1. At least 8 years’ experience in a quality regulated industry, pharmaceutical or medical device experience is preferred, QA experience and regulatory submission experience in China is a plus. 八年以上质量管理行业工作经验,有制药或医疗器械 行业工作经验者优先,在中国有 QA 经验和法规提交经 验者优先;
2. At least 8 years in a GMP quality system QA role. 至少八年 GMP 质量系统 QA 工作经验。
3. At least 8 years responsibility for validation of NMPA, EMA or US- FDA licensed pharmaceutical companies. 至少八年 NMPA、EMA 或美国 FDA 许可制药公司验证经 验。
Knowledge skills/abilities required 知识技能/能力要 求
1. Proficiency in the use of common Microsoft office applications. 熟练使用常用 Microsoft office 应用软件;
2. Demonstrated leadership experience with personnel management development and accountability. 在人事管理发展和责任方面具有领导经验;
3. Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines. Well organized and detail oriented professional. 必须自我激励,有能力独立处理、组织和确定多项任 务的优先顺序,并能在压力下完成工作,能在最后期 限内完成任务。良好的组织能力和注重细节的专业人 士