北京招聘

Job Purpose
工作目的

The role is responsible for the release of product and overall quality management within the PU, This role ensures that the quality strategy is implemented and that there is a continuous drive to improve product and process quality within the PU.

The role is responsible for the site level process validation and cleaning validation. And the role is also responsible for compliant investigation involved S-PU products and site level suspicious counterfeit handling.

负责 PU内的产品放行和全面质量管理，确保质量方针在PU内的实施， 持续推动和提高PU内产品工艺和产品质量。本职位还负责全厂工艺验证和清洁验证以及负责涉及到S-PU产品的投诉调查和全厂疑似假药的处理。

Major Accountabilities
主要职责

1. Act as the delegation of Quality Head who is responsible for compliance with technical or regulatory requirements related to the quality of finished products and the approval of the release of the finished product for sale or supply. Ensure that the following requirements have been met;
作为成品放行授权人，保证成品质量符合技术方面的要求和法规要求，并批准成品放行用于市场或供应。确保满足以下要求：
Ø The marketing authorization and the manufacturing authorization requirements for the product have been met for the batch concerned; 确保批次产品符合市场准入要求和生产合规要求；
Ø The principles and guidelines of GMP, as laid down in the guidelines published by HA, have been followed; 确保遵循卫生管理部门颁布的GMP原则和指导方针；
Ø The principal manufacturing and testing processes have been validated, if different; 关键生产工艺和检验方法变更时要经过验证；
Ø All the necessary checks and tests have been performed and account taken of the production conditions and manufacturing records; 确保所有必要的检查和测试的实施，并考虑生产环境和生产记录；
Ø Any planned changes or deviations in manufacturing or quality control have been notified and evaluated in accordance with a well-defined system before any product is released. Such changes may need notification to, and approval by, the medicines regulatory authority; 在产品放行前，任何生产或质量控制中计划性变更和偏差需要通过健全的系统来进行汇报和评估，这些变更可能需要通知药品监管机构并经药品监管机构批准；
Ø All necessary production and QC documentation has been completed and endorsed by coordinators trained in appropriate disciplines; 所有必要的生产和 QC文件已完成且已经由培训过的协调员核准过；
Ø The approval of QC report has been given by the QC responsible person; 确保QC报告经QC责任人批准;
Ø All relevant factors have been considered, including any not specifically associated with the output batch directly under review (e.g. subdivision of output batches from a common input, factors associated with continuous production runs). 审核批文件要考虑所有相关因素，包括与产品没有明确关联的因素（例如正常批次的分批，连续生产批次的影响因素）。
2. Evaluate batch records including QC testing records and manufacturing/packaging records, and release the finished product timely; 评估批记录，包括实验记录和制程/包装记录，并及时放行成品；
3. Oversee the PU related hygiene; 监督生产车间卫生相关事宜；
4. Oversee the performance and evaluation of in-process controls; 监督中间控制的执行和评估；
5. Make sure records required by SOP/GMP are archived accordingly; 确保记录按SOP/GMP的要求存档；
6. Monitor the compliance with GMP requirements; 监控GMP合规情况；
7. Ensure the processes for inspection, investigation and taking of samples in order to monitor factors that may affect product quality; 确保检查、调查和取样的相关流程，以监控可能影响产品质量的因素；
8. Ensure that the appropriate validations, including those of analytical procedures, and calibrations of control equipment are carried out; 确保适当的验证，包含分析方法验证及控制设备的校验按规定进行；
9. Ensure deviation, compliant and suspicious counterfeit are conducted in compliance with the regulatory requirement and Novaritis related policies; 确保偏差、投诉和疑似假药工作符合法规要求和诺华相关政策；
10. Ensure process validation and cleaning validation are conducted in compliance with the regulatory requirement and Novaritis related policies; 确保工艺验证和清洁验证工作符合法规要求和诺华相关政策；
11. Ensure that the required initial and continuing training of PU QA personnel is carried out and adapted according to need; 确保PU QA员工所需的初始培训及持续性培训的进行，并根据需要调整培训内容；
12. Lead and develop the PU Quality Team ensuring GMP compliance and continuous quality improvement; 领导和发展PU质量团队，确保GMP合规，保证持续性的质量提高；
13. Ensure quality processes are maintained correctly and timely according to current Novartis Policies ( Novartis Quality Manual ) within the PU to ensure compliance with regulatory standards; 确保PU内质量规程依据现行版的诺华政策（诺华质量手册）进行及时正确的维护，确保符合法规标准；
14. Ensure consistency of quality related processes and procedures within the PU; 确保PU内质量相关工艺和过程的一致性；
15. Ensure timely and compliant QC testing and QA release of products from the PU to the market place; 确保从PU到市场的产品的QC检测和QA放行的及时性和合规性；
16. Work with the PU team to improve quality management; 与PU共同提高质量管理水平；
17. Act as deputy and delegation of Quality Head in some responsibilities. Details refer to FRM-7010159; 作为质量部负责人的代理人和授权人，完成质量部负责人的一些职责，详见FRM-7010159；
18. Participate in establishment, implementation and maintenance of the quality system, ensure and monitor effectiveness of quality systems within the PU; 参与质量体系的建立、执行和维护，确保和监督生产运营部门质量系统的有效性；
19. Participate in internal/external audit (vendor audit); 参与内部/外部审计(供应商审计)；
20. Ensure, together with the Compliance Team, that quality systems such as laboratory investigation, complaints, deviation management and change control are in place; 与合规组一起，确保工厂质量系统的管理（如实验室调查、投诉、偏差管理及变更控制）；
21. Establish and maintain IQP mentality across unit; run and coach IQP projects utilizing IQP tools and methodologies; 建立并维护部门IQP思维方式， 使用IQP工具和方法领导和指导IQP项目；
22. Drives continuous improvement to enable Process Unit performance to remain competitive and compliant; 持续提高部门绩效以保持本部门的竞争力和合规性；
23. Economic management of costs and investments (e.g., by efficient planning and utilization of technical and human resources); 成本和投资的合理管理（如，有效计划和合理利用技术资源和人力资源）；
24. POO ambassador, and act as a role model in accordance with the Novartis Values and Behaviors and the leadership standards. Develop and strengthen the POO culture by facilitating and promoting empowerment and accountability; 作为POO大使，要成为体现诺华行为价值观和领导力标准的典范。通过促进和推动授权和责任制，发展和加强POO文化；
25. Act a sponsor for potential talents to develop the talent pipeline 发掘有潜质的人才，发展人才梯队；
26. Ensure the coaching and training of PU QA team and other associates within the PU in quality management; 确保PU QA团队和PU内的相关人员得到质量管理方面的辅导和培训；
27. Support PU Objectives are in compliance with Quality, Customer Service, HSE, and regulatory requirements; 支持PU 的目标符合质量、客户服务、HSE（健康安全与环境）和法规要求；
28. Ensure health & safety procedures are followed within PU QA team i.e. near miss accidents, workstation assessment etc. 确保PU QA 人员遵循健康和安全程序，如未遂事件和工作区域的安全评估等。

29. Support the training program, including the application and principles of QA; 支持培训程序，其中包括QA培训程序的应用和相关原则；
30. Oversee the program of designation and monitoring of storage conditions for materials and products; 监督物料和产品储存条件的设计和相关程序的监控；

Ideal Background
理想的背景
Education教育:
Life Science degree (Pharmacist, Chemist or equivalent scientific Education) plus eligible to act as deputy of Authorized Person under SFDA/BDA regulation 生命科学（药学、化学或相关科学专业教育）并有资格作为SFDA/BDA备案的质量授权人的代理人
Languages语言:
Local language and English fluent in speaking / writing 对于母语和英语具有流利的表达能力和较强的写作能力
Experience工作经验:
Min. 5 years’ experience of management of production and quality, including experience in in-process control and quality control. 具有至少五年从事药品生产和质量管理的实践经验，包括从事过药品生产过程控制和质量检验工作

Pharma operation - 北京诺华制药有限公司 北京昌平制药工厂诚聘