天津招聘

Key Responsibilities/主要职责

PMS 80%

· Support to collect quality related complaint investigate the complaint and report to Ortho global, Ensure the handled complaints are logged in GOCP system on time;

· Screen potential adverse event and work with MA for AE reporting. Liaise with HK/TW team for corresponding action. Update the local reported AE in the Trackwise system.

· Work with global CHU team to assess the China reportable oversea case and do the reporting in NMPA system and timely updates in Trackwise until closure.

· Prepare the period risk evaluation report based on each registration license to ensure the report is in place to support registration lifecycle.

· Manage Field safety corrective actions, including Stop shipment, recall, market withdraw, field corrective action, etc. Timely report to NMPA in each state. Liaise with HK/TW team for corresponding actions.

· Collect the recall data of competitors.

· Ensure all the records for AE, Recall, Complaints owned by QA are well archived and can be provide in the external audit.

Document and Record Control 10%

· Manage all quality documents with tracking status of effective/invalid/ongoing;

· Manage some of quality records including log sheet and hardcopies, like: CCA, DML, training file.

Others 10%

· Other assignment from supervisor or emerging business need.

Backup to Support RA team for the Chop

Key skills/ Critical experience关键技能/经验标准

• l University degree or equivalent in Life or Health Sciences required.
• l Excellent bilingual oral and written communication skills (Fluent in English and Chinese).
• l Personality of : Follow procedures; Team spirit; Patient, Detail-oriented

Ortho Clinical Diagnostics is a global in vitro diagnostics leader serving the global clinical laboratory and transfusion medicine communities. Worldwide, across hospitals, hospital networks, blood banks, and commercial and specialty labs, our high-quality products and services enable healthcare professionals to make better medical decisions to improve and save lives. Ortho Clinical Diagnostics serves the global transfusion medicine community with donor screening and blood typing products to help ensure every patient receives blood that is safe, the right type and the right unit. Around the world, Ortho Clinical Diagnostics brings sophisticated testing technologies, automation, information management, and interpretation tools to clinical laboratories to help them run more efficiently, effectively and improve patient care. For more information, visit ********************************.
Ortho Clinical Diagnostics 的总部设立于美国新泽西州拉里坦，在美国纽约州曼彻斯特、美国佛罗里达州庞帕诺比奇、法国斯特拉斯堡和英国威尔士州彭科伊德设有分公司。我们在全球拥有约 3,800 名员工，销售、营销和物流网络遍布六大洲。我们是实力雄厚、极具竞争力的机构，年销售额高达 20 亿美元。这一成功业绩源自两大业务领域，即临床实验室业务和输血医学业务。 临床实验室测试在疾病的检测、诊断和监控中发挥重要作用，可谓生死攸关。测试聚焦于血液和其他体液的分子和细胞要素，用于疾病的诊断和管理。Ortho Clinical Diagnostics 持有专利的病理晾片化学技术和系统用于统计和随机存取体外诊断测试。经过增强的化学荧光技术和系统在甲状腺机能、生殖内分泌学、心脏病学、贫血、新陈代谢、肿瘤学和传染病等各大类别中提供免疫测定测试功能。 我们的第二大业务领域是输血医学业务。将近 70 年来，我们始终是输血医学领域的全球领导者。我们的系统和产品在全世界最为深受信赖，确保患者和供体之间的兼容性，并通过筛查艾滋病 (AIDS)、肝炎和美洲锥虫病等疾病，协助保护全世界血液供应的安全。