QA Specialist

Location:

Guangzhou, Guangdong, China

Job Responsibilities岗位职责：

1. Document Management文件管理：

• Be responsible for the full life cycle management of GMP documents, CMC documents and technology transfer documents, ensuring the accuracy, systematization and completeness of the document archive.  负责药品GMP文件、CMC文件、技术转移文件的全生命周期管理，记录归档，保证文件管理的准确性、系统性与完整性。

• Be responsible for maintaining management procedure of standard operating procedures (SOP), including maintaining the company's SOP list and ensuring the timeliness and accuracy of SOP list updates; Coordinate with the SOP authors to complete periodic revisions; Manage the numbering, format review, electronic approval (DocuSign), archiving， and other aspects of the SOP.  负责标准操作规程（SOP）制订与管理规程的修订，包括维护公司SOP目录，保证SOP目录更新的及时性、准确性；协调SOP作者完成周期性修订；负责SOP 的编号、形式审核、电子签批（DocuSign）、归档等管理。

• Organize SOP training and supervise its implementation. 组织SOP生效培训并监督执行情况。

2. Quality Management质量管理：

• Maintain the change control and CAPA systems and track the completion status and effectiveness of action items. 维护变更控制和CAPA系统，跟踪行动项完成状态及有效性。
• Ensure the effective implementation of all major deviations and OOS management and follow up the completion status and effectiveness of CAPA action items. 确保所有重大偏差和检验结果超标管理的有效执行，跟踪CAPA行动项的完成状态、有效性

3. Review CMC section of the registration documents to ensure accuracy and compliance of the data. 审核注册申报资料中CMC部分数据，确保数据准确性和符合性

4. Assist in reviewing CMO`s Batch Production Records (BPR) and Batch Test Records (BTR) to ensure compliance with the specification and registration requirements. 支持审核受托方的批生产记录（BPR）和批检验记录（BTR），确保符合注册文件、放行标准。

5. Vendor Management（including CMO，CLO） 供应商管理（物料及委托第三方服务）：

• Participate in developing the on-site audit protocol for vendors, facilitate vendor qualification/approval, establish a list of qualified suppliers, and maintain management files for qualified suppliers. 参与制订供应商审计方案，组织对供应商的确认和批准，建立合格供应商名录，维护合格供应商管理档案。

6. Other related work assigned by superiors. 上级安排的其它相关工作。

Qualifications任职要求：

1. Major in biopharmaceuticals, pharmacy or related fields, Bachelor's degree or above. 生物制药/药学等相关专业，本科及以上学历。

2. Work Experience requirements工作经验要求：

• At least 2 years in commercial drug manufacturing and quality management, the biopharmaceutical industry is preferred. 至少具有2年以上商业化药品生产质量管理经验，生物制药行业优先。

3. The ability to review batch production records and batch test records is preferred. 具备审核批生产记录和批检验记录的能力优先。

4. Excellent English reading and writing skills. Proficient in simple English communication. 优秀的英语读写能力，英语口语能简单沟通。

5. Strong sense of responsibility, meticulous and rigorous in work, and a spirit of teamwork. 具有高度责任心，工作严谨细致，有团队合作精神。

6. Strong communication skills, able to efficiently communicate with colleagues from different departments and external partners. 具有良好的沟通能力，可胜任与不同职能部门同事及合作方的高效沟通。

About Angitia:

Established in June 2018, Angitia Biopharmaceuticals is a multinational research and development enterprise focusing on discovery and development of new drugs for grievous bone, muscle and joint diseases. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development and management from both overseas and domestic large multinational companies. The company has built an organization distinguished by world-class scientists with talents that proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science includes internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking people who are competent, ambitious and great team players to join our vibrant group.

Our mission is to discover, develop and commercialize breakthrough therapeutics that address the key unmet medical needs of serious musculoskeletal diseases.