质量放行经理QA Manager (release)

岗位描述：
1. 产品放行管理 Product Release Management
1.1 负责产品放行前对批生产记录进行审核、汇总；Responsible for reviewing and summarizing batchproduction records before product release;
1.2 负责产品放行前对批检验记录进行审核、汇总；Responsible for reviewing and summarizing batchanalysis records before product release;
1.3 负责产品放行后对批档案的整理、归档；Responsible for organizing and archiving batchfiles after product release;
1.4 负责产品发运的现场监督；Responsible for on-site supervision of product delivery.
2. 物料放行管理 Raw Material Release Management
2.1 负责物料放行前对批物料记录进行审核；Responsible for reviewing and approvalling batchraw material records before raw material release;
2.2 负责物料放行的批准； Responsible for approvalling raw material release;
2.3 负责物料放行后对批档案的整理、归档。Responsible for organizing and archiving batchfiles after material release.
3. 质量保证体系 Quality Assurance System
3.1 建立相关的质量保证体系文件； Establish quality assurance system documents;
3.2 参与产品相关的质量风险管理，如风险识别、风险评估、风险控制等；Participate in product-relatedquality risk management, such as risk identification, risk assessment,risk control, etc.;
3.3 参与GMP自检。 Participate in GMP self-inspection .

任职要求：
1. 生物技术、制药或相关专业本科以上学历； Bachelor degree or above in biotechnology,pharmacy or related field;
2. 10年以上制药行业工作经验；具有质量保证、质量审计经验者优先；At least 10 years working experiencein pharmaceutical industry. Experience in quality assurance and qualityauditor is preferred;
3. 具备起草和审核sop的能力； Capable of drafting and reviewing SOP;
4. 良好的计算机操作技能，包括Microsoft Word, Excel, Powerpoint； Good computer skills,including Microsoft Word, Excel and Powerpoint;
5. 熟悉GMP和相关法规的要求。 Familiar with the requirements of GMP and relevant regulations.

关键能力：注重细节、沟通技巧、数据收集与分析、问题分析与解决。
Key skills: attention to details, communication skills, data collectionand analysis, problem analysis and solution.