北京招聘

Job Responsibility：

1. 负责起草及审阅公司GMP文件管理相关文件，协助质量经理建全和维护公司的GMP文件管理系统；

Responsible for drafting and reviewing company GMP related document management, assist quality manager to improve and maintain the company's GMP documentation system;

2. 负责公司验证工作的管理及协调工作，确保验证工作能够顺利完成；负责起草公司验证主计划并跟进设备、仪器IQ/OQ/PQ，工艺验证、检验方法验证等验证工作的执行情况；

Responsible for validation management, coordinate and ensure the validation related tasks can be implemented accordingly. Responsible for drafting the validation master plan and follow up implementation of validation work, including but not limited to company equipment, instruments of IQ/OQ/PQ, process validation, and inspection methods, etc.;

3. 负责公司偏差及CAPA工作的管理；组织协调调查及追踪行动完成情况;

Responsible for deviation and CAPA management. Organize and coordinate relevant investigation and follow up actions.

4. 负责起草培训计划，按计划协调开展公司员工的专业知识和法规培训工作，并确认各部门培训的实施效果；负责建立和维护公司员工个人培训档案，负责公司员工培训资料的整理、归档；

Work out training plan and deploy training on professional knowledge and regulation to staff, and ensure training effects. Responsible for establishing and maintaining employee training files, and sorting, filing company's training materials;

5. 负责公司成品的放行审核；

Responsible for reviewing of final product batch release.

6. 负责组织公司内部审计、年度质量回顾及管理评审工作；

Responsible for organizing and participating internal audit and annual product quality review.

7. 完成上级领导安排的其他工作。

Complete others tasks assigned by line manager.

Qualification：

1． 药学、生物相关专业本科以上学历

BS or Master Degree, majoring with pharmacy, biology, or other equivalent areas;

2． 5年以上制药行业QA工作经验，熟悉国内外GMP及相关指南和法规要求；

5 years or above QA related working experience in pharmaceutical industry, be familiar with domestic and international GMP and related guidelines and regulations;

3． 熟悉制药行业GMP文件管理，验证及人员培训；

Be familiar with document management, checking and personnel training of GMP.

4． 具有较强的学习、分析和处理解决问题的能力，能够从工作中不断总结经验，优化流程；

Strong capability of learning, analysis and problem-solving, good at summarizing experience and optimizing procedures.

5． 协调沟通、语言表达能力较好；工作认真细致；

Good communication and presentation skills, conscientious working attitude.

6． 具有良好的英文读写能力，能熟练使用Office办公软件；

Good English reading and writing ability, skilled use of Office Software.

7． 同时熟悉QMS 中变更控制、内部与外部审计、供应商管理、产品投诉管理中一项或多项者优先。

Simultaneously familiar with one or multi facets within QMS area will be preferable, the facets are included but not limited to change management, internal and external audit, supplier management and product complaint management.

舒迪安是一家跨国的生物技术公司，致力于开发基于活化树突状细胞的新治疗方法，主要专注癌症和自体免疫性疾病的治疗。我们的使命是采用基于我们自有知识产权的细胞技术并通过我们自有的免疫疗法平台来开发新的治疗产品，为目前人类未得到满足的医疗需求提供世界前沿的拓展治疗手段。一大批世界知名科学家聚集在舒迪安公司总部位于布拉格的研究中心，他们借助于目前最尖端的实验设备积极探索树突状细胞在免疫反应活化治疗中的应用。

舒迪安公司通过下列方式开发最新治疗方法：
采用自体细胞免疫疗法治疗癌症和自体免疫疾病
采用免疫疗法配合化疗等其他标准治疗方式提高临床疗效
研究免疫疗法的长期治疗效果以增强免疫系统对特定疾病的反应能力
使用广谱的肿瘤抗原，通过患者自身树突状细胞的活化，来刺激复杂的免疫反应

舒迪安公司的临床开发方案旨在采用活化树突状细胞免疫疗法，其自体细胞肿瘤免疫治疗产品为某些特定的、现有治疗手段匮乏的部分疾病拓展治疗选择。舒迪安在欧洲和中国北京建设了GMP标准细胞实验室，所生产的基于细胞的医疗产品均符合全球监管标准。

针对不同的癌症（前列腺癌、肺癌、卵巢癌等），舒迪安公司正在开展基于成熟树突状细胞负载免疫原性死亡肿瘤细胞技术的肿瘤免疫疗法的临床应用。多个单病种癌症的临床试验结果验证了舒迪安产品的临床安全性和有效性，显示出了令人振奋的临床治疗效果。

公司地址：北京亦庄经济开发区科创14街汇龙森科技园30号楼B座
市内办公室: 北京朝阳区亮马桥路50号燕莎写字楼C214

Company Introduction
SOTIO is a European biotechnology company developing new therapies based on activated dendritic cells, focusing on the treatment of cancer and autoimmune diseases. Our mission is to develop new medical therapies using our proprietary cell-based technologies to treat highly unmet medical conditions using our immunotherapy platform. Sotio (Beijing), a fast growing subsidiary focusing on China market, is looking for talented, motivated, dynamic employees to join its international team. The company can provide tremendous career development opportunity to its employees.

SOTIO is an Equal Employment Opportunity/Affirmative Action Employer
The policy and practice of SOTIO require that entry into employment and progression within employment will be determined only by personal merit and the application of criteria which are related to the duties of each particular job. Subject to statutory provisions, no applicant or member of staff will be treated less favorably than another because of his or her gender, marital or civil partnership status, sexual orientation, religion or belief, racial group, age or disability. In all cases, ability to perform the job will be the primary consideration.